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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. CATH PKGD: PACING 5 FR 110CM 25MM SPACIN CATHETER, ELECTRODE Back to Search Results
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.
 
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Brand NameCATH PKGD: PACING 5 FR 110CM 25MM SPACIN
Type of DeviceCATHETER, 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 Key6186440
MDR Text Key62749925
Report Number3010532612-2016-00035
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2017
Device Catalogue NumberAI-07155
Device Lot Number16F16E0089
Other Device ID Number00801902002396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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