MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 36"(90CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	M8556
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product 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 that a patient underwent an aortic valve replacement surgery on an unknown date and suture was used.During the procedure, when taking out the needle-suture from the package, the nurse noticed that the needle had been protruded from the package.The nurse was not pricked skin since the nurse wore double gloves.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Evaluation: 1) there was no sample received for analysis.Only pictures of the sample were received for analysis.Upon visual inspection of the picture,an unopened sample of product with the tip of the needle out of the sterile package could be observed.However, no conclusion could be reach how this happen as the sample was not returned for analysis.2) an opened overwrap with an unopened folder and three unopened samples of product were returned for analysis.During the visual inspection of the opened sample, the tip of the needle outside of the package could be observed.The needle trespasses the folder and overwrap compromising the sterile barrier.Three unopened samples were inspected, and no defects were observed on the packages. the samples were opened and the four needles were correctly placed in the foam park.In addition, no attachment issues, damage or defect were found.  the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the condition of the sample, the assignable cause of packaging ¿ integrity is pin hole in package observed.3) per the condition of the unopened representative samples, no packaging integrity issue was observed.

• Brand Name: PROLENE SUTURE 36"(90CM) 5-0 BLU
• 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: 8353892
• Report Number: 2210968-2019-78961
• Device Sequence Number: 19364641
• Product Code: GAW
• UDI-Device Identifier: 10705031045729
• UDI-Public: 10705031045729
• 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): 01/22/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: M8556
• Device Lot Number: MGH809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1