MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP494G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The following information was requested, but unavailable: lot #? the lot number is unknown.When was it noticed that the needle detached from the suture? - pre-op-- before used on patient? or intra-op-- during use on patient ? no further information is available.Was procedure completed successfully? and how? no further information is available.No further information will be provided.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The suture was found that the needle had been detached from the suture.It was not a control release needle.There were no adverse patient consequences reported.

• Brand Name: PDS PLUS CLR 18IN 4-0 S/A P-3 PRM MP
• 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: 8745108
• Report Number: 2210968-2019-83436
• Device Sequence Number: 1488714
• Product Code: NEW
• UDI-Device Identifier: 10705031048416
• UDI-Public: 10705031048416
• 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
• Report Date (Section B): 06/06/2019

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 Catalogue Number: PDP494G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1