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

Catalog Number	381357
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: BD INSYTE-W¿ IV CATHETER WITH WINGS 16GA 1.77IN (1.7 X 45 MM)
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9356202
• Report Number: 8041187-2019-00928
• Device Sequence Number: 458628
• Product Code: FOZ
• UDI-Device Identifier: 30382903813576
• UDI-Public: 30382903813576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 381357
• Device Lot Number: 8326838
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other