MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number SXPP1B410

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Summary: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual evaluation of the picture, an opened box labeled product code sxpp1b410 could be observed.Additionally, inside box a package foil for product code sxpp1b415 was noted.The cause could not be determined and no further investigation can be conducted since the sample was not returned.The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that while prepping for an unknown procedure on (b)(6) 2018 and when opening the box of sutures, the sutures inside were not what was ordered.Another like device was used to complete the procedure.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Device evaluation summary: an opened box of product code (b)(4), lot mcj439 with eleven unopened samples of product code (b)(4) lot mcj625 were returned for analysis.During the visual inspection of box, the cellophane wrap was removed and the box was received opened and contains eleven samples.In addition, no defects were found on the packets.The impression of the box does not match the product inside the box (mismatched).Per the condition of the sample, it could not be determined what may have caused the reported incident.

• Brand Name: STRATAFIX SPIRAL PDS+
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7644512
• MDR Text Key: 112566069
• Report Number: 2210968-2018-73914
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236134
• UDI-Public: 10705031236134
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: SXPP1B410
• Device Lot Number: MCJ439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1