MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDPB340
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were there any adverse patient consequences as a result of "the surgeon was having difficulty for hemostasis".Was the procedure completed successfully?.
Event or Problem Description
It was reported that a patient underwent a caesarean section on an unknown date and suture was used.During the procedure, the needle was detached from the suture at 1st passing of the needle through the myometrium.Accordingly, the surgeon was having difficulty for hemostasis.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: it was received for analysis a paper lid, a winding former a detached needle and a suture piece of product code pdpb340.During the visual inspection of the needle, the swage and attachment area were as expected, and remnant of the suture was noted into the barrel hole and marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.In addition, the ends of the suture were cut appears to be by use of the surgical instrument.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the sample condition the assignable of the performance - pull off suture needle, suggest an improper handling of the sample.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information was requested and the following was obtained: were there any adverse patient consequences? there were no adverse consequences to the patient.Was the procedure completed successfully?: no further information is available.No further information will be provided.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8499399
• Report Number: 2210968-2019-80194
• Device Sequence Number: 1884114
• Product Code: NEW
• UDI-Device Identifier: 10705031048799
• UDI-Public: 10705031048799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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,Followup
• Report Date (Section B): 03/14/2019

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: 04/30/2020
• Device Catalogue Number: PDPB340
• Device Lot Number: MEZ580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 06/23/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/01/2019; 07/17/2019
• Patient Sequence Number: 1