MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J494G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.1.How long was the delay? 15 minutes delay.2.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no unexpected outcomes or complications reported.3.Was there any change in the patient¿s post-operative care due to the prolonged procedure? no changes to patients post-operative care.4.Was there any additional tissue damage as a result of searching for the needle piece? no additional tissue damage reported.5.Status of product return: affected product will be returned on (b)(6) 2024.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2024 and suture was used.During procedure, in the cath lab, while closing incision in chest, the needle broke off the suture and went inside of patient.They used a fluoroscopy to locate the needle and remove it.Case was completed but delayed 15 minutes.No patient harm reported.Product is available for return.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 investigation summary: the product was returned to ethicon for evaluation.Four representative unopened samples was received for analysis.Product code j494g.Upon initial inspection of the samples, no external damages were observed on the external packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related no defects were observed during evaluation.A functional test was performed using instron equipment, and the pull force results were above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.It should be noted that as part of our quality process, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Additional devices have been received, however clarification is requested whether the product belongs to this complaint.The following information was requested from the sales rep: our analysis lab received under (b)(4), (4) j494h; lot# uammtc ; in addition we received (1) j494h; lot# tbmdrr; from: 455 tollgate rd warwick, ri 02886; the ro-1040638 was created for cg labs to ship the device out to the analysis site.Please confirm the pcf outcome regarding the lot#tbmdrr received in this complaint.Please clarify this mismatch.Our analysis lab received product with reference to this complaint, the following product was received: this complaint is for product code: j494g; lot# uammtc.1.Could you please clarify if the returned device belongs to this complaint? 1a.If yes, did a device malfunction occur during the same procedure? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.Part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: h6.The following additional information was received: additional information received from the sales rep via email on oct 22, 2024: our analysis lab received product with reference to this complaint, the following product was received: this complaint is for product code: j494g; lot# uammtc.1.Could you please clarify if the returned device belongs to this complaint? the 1 each received of item# j494h (lot# tbmdrr) was mixed there in error.1a.If yes, did a device malfunction occur during the same procedure? n/a 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.N/a 3.If the device was not reported before, please provide more details of device malfunction.N/a.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.The 1 each received of item# j494h (lot# tbmdrr) was mixed there in error.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex.N/a.

• Brand Name: VCL CT BRD UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20265436
• Report Number: 2210968-2024-10082
• Device Sequence Number: 8298751
• Product Code: GAM
• UDI-Device Identifier: 10705031040526
• UDI-Public: (01)10705031040526(17)281231(10)UAMMTC
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: J494G
• Device Lot Number: UAMMTC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 10/22/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/18/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown