MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; INTRAVASCULAR 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	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 blood leaked through a hole in the bd cathena¿ safety iv catheter during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "there was a tiny hole on the catheter; when the hcp placed the catheter, blood leaked.".
Additional Manufacturer Narrative
H6: investigation summary seven photos, sixty-three representative samples, and one used adapter with the catheter intact were received by our quality team for evaluation.From the photos, a damaged catheter was observed.A hole in the the catheter tubing was observed on the returned used sample.The representative samples were subjected to visual inspection and the catheter leak test, and no abnormalities were observed.The quality team was able to confirm the customer experience as the used catheter failed the catheter leak test.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.From the investigation, the leakage is caused by the hole in the catheter.A review of the manufacturing process found that this nonconformance occurred when the production technician changed the time setting at the tip quality check station which caused the mandrel to hit the tubing.The time setting has been adjusted and awareness training for this nonconformance has been conducted.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.See h.10.
Event or Problem Description
It was reported that blood leaked through a hole in the bd cathena¿ safety iv catheter during use.The following information was provided by the initial reporter, translated from japanese to english: "there was a tiny hole on the catheter; when the hcp placed the catheter, blood leaked.".

• Brand Name: BD CATHENA SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10656108
• Report Number: 8041187-2020-00655
• Device Sequence Number: 3219919
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201717
• 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): 12/03/2020

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: 9108915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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