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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER WITH WINGS 16GA 1.77IN (1.7 X 45 MM); INTERVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER WITH WINGS 16GA 1.77IN (1.7 X 45 MM); INTERVASCULAR CATHETER Back to Search Results
Catalog Number 381357
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified number of bd insyte-w¿ iv catheter with wings 16ga 1.77in (1.7 x 45 mm) experienced a loose needle which was noted prior to use.The following information was provided by the initial reporter: after removing the protective cover of the needle, the needle starts rotating inside the catheter and does not stop.A safe insertion cannot be guaranteed.The same incident was reported for other products of the same lot, but they are not available.The problem was detected before use.
 
Manufacturer Narrative
Investigation summary: one sample was received by our quality team for evaluation.Upon visual inspection it was observed that the needle hub was damaged which may have caused the catheter to rotate; therefore, the incident can be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Conclusion: based on the investigation the probable root cause could have been that the hub was damaged during manufacturing when the hub was picked up and placed by a gripper.The production technicians were informed of the issue and the gripper had additional maintenance done.
 
Event Description
It was reported that an unspecified number of bd insyte-w¿ iv catheter with wings 16ga 1.77in (1.7 x 45 mm) experienced a loose needle which was noted prior to use.The following information was provided by the initial reporter: after removing the protective cover of the needle, the needle starts rotating inside the catheter and does not stop.A safe insertion cannot be guaranteed.The same incident was reported for other products of the same lot, but they are not available.The problem was detected before use.
 
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Brand Name
BD INSYTE-W¿ IV CATHETER WITH WINGS 16GA 1.77IN (1.7 X 45 MM)
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key9356202
MDR Text Key178613820
Report Number8041187-2019-00928
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903813576
UDI-Public30382903813576
Combination Product (y/n)N
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number381357
Device Lot Number8326838
Initial Date Manufacturer Received 11/04/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received11/04/2019
Supplement Dates FDA Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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