MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM TUBING SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5552003
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.When the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
As reported, the packaging of the bard/davol x-stream tubing set nd handle w/o tip was noted to be creased and folded on (b)(6) 2021.It is also reported that the packaging was non-sterile, rupturing the sterility barrier.There was no patient involvement.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot of 1200 units released for distribution in october, 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: this supplemental mdr is submitted to report the results of the device evaluation.Initial evaluation of the sample confirms for a breach of the sterile barrier.Based on sample evaluation, after the product was released from bard/davol control the product was subjected to some excessive heat and subsequent force / trauma to the blister end while the package was in a heated state.This resulted in blister deformity and a ¿glazed¿ seal transfer and breach of the sterile barrier.It is anticipated that a force without the excessive heat can result in a cracked blister.The blister deformity and ¿glazed¿ seal transfer indicate the product seeing excessive heat.Based on the sample evaluation and investigation performed, the root cause is heat/ trauma damage to the product packaging while in transit or in hospital inventory.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported, the packaging of the bard/davol x-stream tubing set nd handle w/o tip was noted to be creased and folded on 08-feb-2021.It is also reported that the packaging was non-sterile, rupturing the sterility barrier.There was no patient involvement.

• Brand Name: X-STREAM TUBING SETS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11396211
• Report Number: 1213643-2021-20045
• Device Sequence Number: 19124079
• Product Code: GCJ
• UDI-Device Identifier: 00801741010101
• UDI-Public: (01)00801741010101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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 Expiration Date: 09/28/2023
• Device Catalogue Number: 5552003
• Device Lot Number: JUEW3368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other