MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ IV CATHETER WITH WINGS; INTRAVASCULAR CATHETER

Model Number	381347
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The complaint will be monitored and tracked.Investigation conclusion: the investigation was not able to confirm what customer had experienced as no samples and pictures were returned for investigation.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.Root cause description: based on the quality team's investigation, the root cause of this incident cannot be determined.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that "white hairy matter" was found on the bd insyte-w¿ iv catheter with wings before inserting into the patient.The patient had been admitted to the hospital for "lumbocrural pain".The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2020, our hospital patients by the feeling of lumbocrural pain to live in our hospital, patients on (b)(6) 2020, ready to surgery, the nurse to insert the needle, ready to give patients found indwelling needles with white hairy matter, fortunately, discover in time, after the replacement of indwelling needle to continue the operation.".

• Brand Name: BD INSYTE-W¿ IV CATHETER WITH WINGS
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9930892
• Report Number: 8041187-2020-00199
• Device Sequence Number: 2817454
• Product Code: FOZ
• UDI-Device Identifier: 30382903813477
• UDI-Public: 30382903813477
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/24/2020

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 381347
• Device Catalogue Number: 381347
• Device Lot Number: 9054582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/06/2020
• 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