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

Model Number	386804
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd cathena¿ safety iv catheters experienced catheter damage/deformation which was noted during use.The following information was provided by the initial reporter: my colleagues tell me that they encountered the problem (concerning the 20 ga catheter only) a few months ago and realized that when the patient's vein burst after the catheter was inserted, when they removed the catheter they could see this small plastic clump.However, these incidents were not reported internally and we did not keep the defective samples or record the lot numbers.A few months ago, a nurse noted the problem with at least 2 patients whose vein broke after the catheter was placed (by removing the catheter, she noted a small "heap" of plastic) but she did not keep the units.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of bd cathena¿ safety iv catheters experienced catheter damage/deformation which was noted during use.The following information was provided by the initial reporter: my colleagues tell me that they encountered the problem (concerning the 20 ga catheter only) a few months ago and realized that when the patient's vein burst after the catheter was inserted, when they removed the catheter they could see this small plastic clump.However, these incidents were not reported internally and we did not keep the defective samples or record the lot numbers.A few months ago, a nurse noted the problem with at least 2 patients whose vein broke after the catheter was placed (by removing the catheter, she noted a small "heap" of plastic) but she did not keep the units.

• 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: 10379363
• Report Number: 8041187-2020-00471
• Device Sequence Number: 2160299
• 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 Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/07/2020
• 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