MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUT 18IN(45CM) 5-0 CLR; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP503G
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).A manufacturing record evaluation was performed for the finished device me5213 batch number, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on unknown date and the suture was used.It was also reported that the suture was detached from the needle easily during interrupted suturing.It was not a control release needle.There were no adverse patient consequences reported.

• Brand Name: PDS PLUS SUT 18IN(45CM) 5-0 CLR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9736667
• Report Number: 2210968-2020-01341
• Device Sequence Number: 11381372
• Product Code: NEW
• UDI-Device Identifier: 10705031048454
• UDI-Public: 10705031048454
• 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): 01/26/2020

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 Model Number: PDP503G
• Device Catalogue Number: PDP503G
• Device Lot Number: ME5213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2020
• Initial Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1