MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 22GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386813
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (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 the cathena 22gx1.00in winged bc safety shield remained stuck in the transparent sleeve during use, leaving the needle exposed.The following information was provided by the initial reporter, translated from french to english: as part of the cathena catheter tests, i encountered a problem during the safety of the needle.The white part which is supposed to cover the sharp part of the needle, remained stuck in the transparent sleeve during the security of the needle.Leaving the sharp part of the needle completely accessible.
Event or Problem Description
It was reported that the cathena 22gx1.00in winged bc safety shield remained stuck in the transparent sleeve during use, leaving the needle exposed.The following information was provided by the initial reporter, translated from french to english: as part of the cathena catheter tests, i encountered a problem during the safety of the needle.The white part which is supposed to cover the sharp part of the needle, remained stuck in the transparent sleeve during the security of the needle.Leaving the sharp part of the needle completely accessible.
Additional Manufacturer Narrative
H.6.Investigation summary: no sample was returned for investigation.From the pictures, the adapter was removed, however the tip shield remained in the needle hub.Safety shield activation failure was observed.Dhr review was performed for the reported batch: 8269112 and its an batch: 826915.No similar qn was raised.No abnormality observed in that could have influenced the issue.Conclusion: the photos show the reported non-conformance.The complaint is confirmed, and product is out of specification.The root cause could not be confirmed as the sample was not returned for investigation capa#: 821876 has been raised to address safety activation failure issue.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see section h.10.

• Brand Name: CATHENA 22GX1.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8691486
• Report Number: 8041187-2019-00444
• Device Sequence Number: 2567060
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: 00382903868131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• 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): 09/19/2019

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: 10/22/2021
• Device Catalogue Number: 386813
• Device Lot Number: 8269112
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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