MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 8IN 10-0 D/A STC-6; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1713G
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The following are possible batch numbers: batch hjp302, batch klb004.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.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported from a distributor that on an unknown date it was noted different product descriptions on 2 boxes of suture with same product code but different lot numbers.There were no adverse patient consequences reported.No additional information was received.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/12/2020.Additional information: d4 - the actual device batch number associated with this event is not known.The following are possible batch numbers: batch hjp302: mfg.Date - 8/18/2014; exp.Date - 7/31/2019; batch klb004: mfg.Date - 3/19/2019; exp.Date - 2/29/2024.A manufacturing record evaluation was performed for the finished device batch hjp302-1713g and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch klb004-1713g and no non-conformances were identified.Additional h3 device evaluation summary photo : one picture provided for analysis.Upon visual inspection of the picture, two boxes of product code 1713g and the sales type stc-6, however the description of the needles and the draws of shape of the tip of the needles were different at the boxes, one belong to a straight reverse-cutting needle and the other belong to a straight spatula.Due to the difference of graphics on the sample a change was performed to align the labeling with the product inside on the folder.This change was part of a corrective action.

• Brand Name: PRLNE BLU 8IN 10-0 D/A STC-6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8974763
• Report Number: 2210968-2019-86743
• Device Sequence Number: 311433
• Product Code: GAW
• UDI-Device Identifier: 10705031002227
• UDI-Public: 10705031002227
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1713G
• Device Catalogue Number: 1713G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 02/12/2020
• Patient Sequence Number: 1