MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 4-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	8526H
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that was received one open box that pertain to product code 8526h.Upon the visual inspection of the received box, it was found that contained thirty-five packets instead of thirty-six packets.As per product requirements, the box should contain thirty-six packages.In addition, it was noted that the tab dispenser was removed from the box.As part of our quality process, the manufacturing records of this lot-batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.Although no conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The following additional information was received: qty of product involved : 1 => 35 qty to be returned : 1 => 35 a manufacturing record evaluation was performed for the finished device lot number tcbhks, 8526h56 and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.Before use on the patient, it was reported by a sales rep that, there were 35 packages in the box.Visual analysis of the returned sample revealed that was received one open box that pertain to product code 8526h.Upon the visual inspection of the received box, it was found that contained thirty-five packets instead of thirty-six packets.As per product requirements, the box should contain thirty-six packages.In addition, it was noted that the tab dispenser was removed from the box.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PRLNE BLU 30IN 4-0 D/A SH-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18874327
• Report Number: 2210968-2024-02802
• Device Sequence Number: 15422801
• Product Code: GAW
• UDI-Device Identifier: 10705031016644
• UDI-Public: 10705031016644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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: 8526H
• Device Lot Number: TCBHKS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown