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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN046311
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The report states: we still have issues with the syringes available in these kits.The syringes are leaking and cannot be used on the patient.Risk for the patient.We had 16 different individual incidents where i have the syringes back in my office.For each of these incidents the staff has used spare satellites syringes.No individual consequence reported.
 
Event Description
The report states: we still have issues with the syringes available in these kits.The syringes are leaking and cannot be used on the patient.Risk for the patient.We had 16 different individual incidents where i have the syringes back in my office.For each of these incidents the staff has used spare satellites syringes.No individual consequence reported.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe and lidstock (reference files: inp1900073956).The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned sample was returned to the supplier (preox) for function testing.According to the supplier, "leakage found by normal handling, manipulation of plunger increases leakage".A design history review was performed for part#: kz-05501-002 as a part of this complaint investigation.Per eco-051699 (released 03-dec-2018), supplier (preox) made the following changes: kz-05501-002 luer plastic lor syringe: a.Changed plunger material from profax 535 to profax 531.B.Changed to new plunger tool.C.Changed to new mold for blue stopper.D.Changed molding location for the plunger and the blue stopper as follows.Plunger: from fleimaplastic in germany to gpe, germany.Blue stopper: from et, germany to psilkon, germany.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.The reported complaint of the lor syringe leaking was confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for functional testing where according to the supplier, "leakage found by normal handling, manipulation of plunger increases leakage".A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.However, based on the functional testing by the supplier, the potential root cause of this issue is supplier related.A scar has been initiated to further investigate this issue.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9470112
MDR Text Key179438264
Report Number3006425876-2019-01051
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2021
Device Model NumberIPN046311
Device Catalogue NumberJC-05400-B
Device Lot Number71F19F1426
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Date Manufacturer Received01/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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