MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN; CATHETER, ELECTRODE

Catalog Number AI-07155

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It has been reported that after placement in the patient the medical doctor (md) checked the transparent package and found it melted.According to the reported the package seemed thermally deformed.As a result of this issue the catheter was replaced by a new one as a precaution.There was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.The second catheter was inserted successfully.Medical / surgical intervention was not required.

Manufacturer Narrative

Qn#(b)(4).Teleflex received the device for analysis.An empty plastic tray warped and damaged was returned with no catheter.The damage noted with the packaging is consistent with overheating and melting.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The root cause of the reported complaint is undetermined.Teleflex assessed the risk for the reported complaint and there are no new or revised risks.A non-conformance has been initiated to further investigate the cause of this issue.Teleflex will continue to monitor for any trends.

Event Description

It has been reported that after placement in the patient the medical doctor (md) checked the transparent package and found it melted.According to the reported the package seemed thermally deformed.As a result of this issue the catheter was replaced by a new one as a precaution.There was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.The second catheter was inserted successfully.Medical / surgical intervention was not required.

• Brand Name: CATH PKGD: PACING 5 FR 110CM 25MM SPACIN
• Type of Device: CATHETER, ELECTRODE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 6186440
• MDR Text Key: 62749925
• Report Number: 3010532612-2016-00035
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: AI-07155
• Device Lot Number: 16F16E0089
• Other Device ID Number: 00801902002396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1