MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W WINGED PNK 20GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381337
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.381337, batch no.8265333.It was reported that during use of the insyte-w winged pnk 20ga x 1.88in the customer is experiencing issues with the catheters since the packaging has changed, catheters are difficult to thread, seem dull, and dislodge.The date/time and or patient information is unknown.The following information was provided by the initial reporter: the catheter is sometimes challenging to advance, the catheters dislodge, the catheters seem duller, these issues did not seem to occur in the same device (same cat #) with the old packaging, as soon as packaging changed, issues began.
Additional Manufacturer Narrative
H.6.Investigation: ¿1 photo as shown in attachment b was returned for evaluation.¿from the returned photo, it was unable to determine what had cause the defect as the pictures only show before and after of the bottom web.¿the complaint is unconfirmed as no samples were received and from the pictures provided, it was unable to determine what had cause the defect.¿the investigation was not able to confirm what the customer had experienced as no samples were received and from the pictures provided, it was unable to determine what had cause the defect.¿a review was performed for the last 12 months of quality notification.¿there was no quality notification was raised for the reported non ¿ conformance ¿no abnormality was observed during the production of the reported batch.H3 other text: see h.10.
Event or Problem Description
Material no.381337, batch no.8265333.It was reported that during use of the insyte-w winged pnk 20ga x 1.88in the customer is experiencing issues with the catheters since the packaging has changed, catheters are difficult to thread, seem dull, and dislodge.The date/time and or patient information is unknown.The following information was provided by the initial reporter: the catheter is sometimes challenging to advance.The catheters dislodge.The catheters seem duller.These issues did not seem to occur in the same device (same cat #) with the old packaging.As soon as packaging changed, issues began.

• Brand Name: INSYTE-W WINGED PNK 20GA X 1.88IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8761028
• Report Number: 8041187-2019-00510
• Device Sequence Number: 1832654
• Product Code: FOZ
• UDI-Device Identifier: 30382903813378
• UDI-Public: 30382903813378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/31/2019

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: 09/30/2023
• Device Catalogue Number: 381337
• Device Lot Number: 8265333
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/31/2019
• 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