MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A404

Device Problems Component Incompatible (1108); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number phz449, and no non-conformances related to the reported complaint condition were identified.Investigation summary: five pictures were received for analysis.Upon visual inspection of the pictures, an opened box of product code sxpp1a404, lot number phz449 could be observed, foil packets of the product code of product code sxpp1a405, lot number pz827 printing on the foil and back foils a label indicating the product code sxpp1a404, lot number phz449.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

Event Description

It was reported on (b)(6) 2020, that it was noted 12 packages of a certain product code were mixed into the device box labeled as a different product code.The whole box should include 12 packages of the one product code.The products were not involved in any surgery.There is no report on patient's injury.No additional information could be provided. .

Manufacturer Narrative

(b)(4).Date sent to the fda: 05/20/2020.Corrected information: h6 device code.3191 - product mix.Additional h3 investigation summary: an opened box of product code sxpp1a404, lot number phz449 with twelve unopened samples of product code sxpp1a405, lot number phz827 were received for evaluation.During the visual inspection, it was noted that the product code and lot number between the box and foil package were different.The box belongs to product code sxpp1a404, lot number phz449 and the foil packets belong to product code sxpp1a405, lot number phz827.All foils were opened, and the paper lid and needle/suture combination correspond to product code sxpp1a405, lot number phz827.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Five pictures were received for analysis.Upon visual inspection of the pictures, an opened box of product code sxpp1a404, lot number phz449 could be observed, foil packets of the product code of product code sxpp1a405, lot number phz827 printing on the foil and back foils a label indicating the product code sxpp1a404, lot number phz449.A manufacturing record evaluation was performed for the finished device lot number phz449, and no non-conformances related to the reported complaint condition were identified.Mfg.Date -7/15/2019.Exp.Date -6/30/2021.A manufacturing record evaluation was performed for the finished device lot number phz827, and no non-conformances related to the reported complaint condition were identified.Mfg.Date -7/17/2019.Exp.Date -6/30/2021.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10000931
• MDR Text Key: 190550064
• Report Number: 2210968-2020-03516
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227699
• UDI-Public: 10705031227699
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: SXPP1A404
• Device Catalogue Number: SXPP1A404
• Device Lot Number: PHZ449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 05/18/2020
• Patient Sequence Number: 1