MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X18IN 7-0 D/A BV-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8701
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.
Event or Problem Description
It was reported a patient underwent a heart bypass surgery on (b)(6) 2018, and suture was used.It was found that two product numbers of m8701 and m8710 were printed on the box before opening the box.The box was not used for the patient.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/20/2019.Investigation summary: it was reported that the device had labeling identification issues.An unopened box with two different labels of product codes m8710 and m8701, lot mgh292 was returned for analysis.The box contains twelve unopened samples and these product codes are multi-strands and requirement four strands double armed per packet.During the visual inspection of sample, a mismatched between labels on box (code m8701, lot mgh292) and code m8710 were observed.For this reason, a characterization of samples was conducted, and the following was observed: twelve unopened overwraps of product code m8701, lot mgh292 were examined and no defects were found on the packages.The samples were opened, and contains four strands per packet, the swage and attachment area of the needles were as expected.Also, all samples were examined by needle characteristic on point type, needle type and needle curvature and suture characteristic and the product contained in each packet belong to product code m8701, lot mgh292.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According the sample condition, the assignable cause of the packaging labeling identification is mixed labels.A picture of the sample was received for analysis.Upon visual inspection of the picture, a closed sample of product code m8710 with lot# mgh292 with a chinese label with a mismatch of the product code could be observed.However, no conclusion could be reached as the device was not returned for analysis.

• Brand Name: PRLNE BLU 4X18IN 7-0 D/A BV-1
• 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: 8195617
• Report Number: 2210968-2018-78002
• Device Sequence Number: 16574475
• Product Code: GAW
• UDI-Device Identifier: 10705031045767
• UDI-Public: 10705031045767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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: 05/31/2023
• Device Catalogue Number: M8701
• Device Lot Number: MGH292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1