MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Model Number	IPN033183
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as "crack on the packaging which compromises the sterility of the product." no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened psi kit for evaluation.Visual inspection of the kit revealed the bottom corner of the tray was broken.Part of the corner was still adhered to the lidstock.Packaging engineers were contacted to identify a potential root cause.Since this complaint is the only one involving this tray (t-04400-100c) it is likely an anomaly and undue force is to blame for the tray damage.A device history record review was performed, and no relevant findings were identified.The report of a sterility issue was confirmed through complaint investigation.Visual analysis revealed that the bottom-right corner of the tray was cracked.A device history record review was performed, and no relevant findings were identified.Based on the customer description, the sample received, and feedback from packaging engineers, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as "crack on the packaging which compromises the sterility of the product." no patient involvement.

• Brand Name: ARROW PSI SET: 8.5 FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12276217
• Report Number: 9680794-2021-00384
• Device Sequence Number: 4663970
• Product Code: DYB
• UDI-Device Identifier: 00801902011206
• UDI-Public: 00801902011206
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K780532
• 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
• Report Date (Section B): 07/20/2021

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: 02/28/2026
• Device Model Number: IPN033183
• Device Catalogue Number: IC-09880
• Device Lot Number: 14F21B0243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1