MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 24"(60CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	D9216
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Photo analysis: an image was received for evaluation and it was determined that foreign matter could be observed inside a closed package with product code d9216.Manufacturing records could not be reviewed because the lot number is unknown.The foreign matter defect has been correlated to the manufacturing process.This product issue will be addressed through ethicon inc.'s quality system.Complaint information will continue to be tracked for potential safety signals through complaint trends as part of post-market surveillance.Additional information was requested, and the following was obtained: event date? no further information is available.Procedure name and date? no further information is available.Lot number? no further information is available.Any presence of blood, insect, hair, or other biological substance found within the primary (sealed) packaging? or is this any presence moisture, material or materials found within the sealed primary package other than the device or one of its components? please see the attached photo.No further information is available.No further information will be provided.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by a sales rep that, during an unknown surgery, on an unknown date suture was used.It was noted that there was foreign matter in the package before use.It was not used for the surgery.There were no adverse consequences to the patient reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: 3/24/2022 h6 component code: g07002 device not returned h3 investigational narrative ¿ photo analysis: an image was received from ethicon inc for evaluation and it was determined that foreign matter could be observed inside a closed package with product code d9216.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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.

• Brand Name: PROLENE SUTURE 24"(60CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13552842
• Report Number: 2210968-2022-01154
• Device Sequence Number: 20098706
• Product Code: GAW
• UDI-Device Identifier: 10705031032446
• UDI-Public: 10705031032446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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 Model Number: D9216
• Device Catalogue Number: D9216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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