MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 3-0 S/A PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z497E

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device mdm411 batch number, and no non-conformance's were identified.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What do you mean by "defect led to disunities of wound scar? please explain: did the suture break intra-op? did the suture knots untie intra-op? any patient consequence/ae outcome as a result of the event report?.

Event Description

It was reported that patient underwent an unknown visceral surgery on (b)(6) 2019 and suture was used.The strand is white and opaque instead of being transparent as usual.The strands are thicker, more rigid and more brittle than usual.Use of another device from different lot to complete the procedure.The patient may have had disunity of wound scar.No treatment was reported.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 2/4/2020.H3 evaluation: eleven unopened samples of product code z497, lot mdm411 were returned for analysis.During the visual inspection of eleven sample, no defects were found on the package.The samples were opened, and the swage and attachment area of needles were noted to be as expected.The sutures were dispensed without problems and examined along of strand and an unusual color could be observed.Functional tests were performed.The tensile strength force was above the minimum requirement and the diameter of sutures was according to requirement.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples received, no suture diameter issue or breakage suture was found since the tested samples met the finished goods requirements.

• Brand Name: PDSII CLR 18IN 3-0 S/A PS-2 PRM
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9545381
• MDR Text Key: 194114767
• Report Number: 2210968-2020-00049
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: Z497E
• Device Lot Number: MDM411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/04/2020
• Patient Sequence Number: 1