MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; INTERVASCULAR CATHETER

Model Number	386804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd cathena¿ safety iv catheters experienced catheter tip damage/deformation which was noted prior to use.The following information was provided by the initial reporter: defective catheter: the plastic that is supposed to remain in the vein forms a small clump of plastic just at the entrance when you check that the needle slides well into the plastic sheath before pricking the patient.The device does not contain product or blood.It was not used because the defect was noticed before use.She used another catheter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: (b)(6)2020.H.6.Investigation: one sample was received by our quality team for evaluation.Inspection of the sample showed no abnormalities, therefore the investigation was not able to confirm the customer experience and the root cause could not be determined.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.
Event or Problem Description
It was reported that an unspecified number of bd cathena¿ safety iv catheters experienced catheter tip damage/deformation which was noted prior to use.The following information was provided by the initial reporter: defective catheter: the plastic that is supposed to remain in the vein forms a small clump of plastic just at the entrance when you check that the needle slides well into the plastic sheath before pricking the patient.The device does not contain product or blood.It was not used because the defect was noticed before use.She used another catheter.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10377126
• Report Number: 8041187-2020-00470
• Device Sequence Number: 19373163
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 8236062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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