MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8402, M ALEXIS O WND PROT/RET 5/BX; PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER

Model Number	C8402
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (receiving inspection).Detailed description of event: cer 1 of 3: (b)(4) - c8304 lot# 1358751 - bug in pouch - 1 pouch.Cer 2 of 3: (b)(4) - c8402 lot# 1358548 - imperfect heat seal - 1 pouch.Cer 3 of 3: (b)(4) - g6313 lot# 1358693 - torn sheath - 1 pouch.The product did not pass the incoming inspection of po#19-10app because of bug.Details are shown on the attached file.Additional information received via email on 30sep2019 from applied medical director packaging: "packaging will need a cer for item 10 (imperfect heat seal)." patient status: na (incoming inspection).Type of intervention: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed that the heat seal on the pouch had delaminated.Testing was performed on the event unit, which confirmed that the sterile barrier had been compromised.Based on the condition of the returned unit, it is likely that the reported event was caused by rough handling during the boxing, shipping, and/or handling processes.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Name of procedure being performed: na (receiving inspection).Detailed description of event: cer 1 of 3: 2019-002370 - c8304 lot# 1358751 - bug in pouch - 1 pouch cer 2 of 3: 2019-002386 - c8402 lot# 1358548 - imperfect heat seal - 1 pouch cer 3 of 3: 2019-002463 - g6313 lot# 1358693 - torn sheath - 1 pouch the product did not pass the incoming inspection of po#19-10app because of bug.Details are shown on the attached file.Additional information received via email on 30sep2019 from applied medical director packaging: "packaging will need a cer for item 10 (imperfect heat seal)." patient status: na (incoming inspection).Type of intervention: na.

• Brand Name: C8402, M ALEXIS O WND PROT/RET 5/BX
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9453822
• Report Number: 2027111-2019-00659
• Device Sequence Number: 11414611
• Product Code: KGW
• UDI-Device Identifier: 00607915117269
• UDI-Public: (01)00607915117269(17)220619(30)01(10)1358548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: No Information
• Device Expiration Date: 06/19/2022
• Device Model Number: C8402
• Device Catalogue Number: 101356201
• Device Lot Number: 1358548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1