MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
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.Based on the quality team's investigation, the root cause of this incident cannot be determined.Investigation conclusion: the investigation was not able to confirm what customer had experienced as no sample/picture was returned for investigation.End user risk assessment: as per risk assessment, (b)(4), severity of catheter defective / damaged is moderate (s3), produced quantity: (b)(4), occurrence is remote (o2).Root cause description: 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 manufacturing of the batch.If samples are received in the future the complaint will be re-opened and re-investigated.Rationale: the complaint will be monitored and tracked.
Event or Problem Description
Hold for ljbp 8.21.2020 it was reported that the bd insyte¿ iv catheter tip tore during the insertion.This occurred on 5 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "insyte 18ga tip torn during insertion report received today from the customer by phone that some iv caths of insyte 18ga were torn on the tip of the cannulas during insertion.It happens several times.Patients complained excessive pain during these insertions.".

• Brand Name: BD INSYTE IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10314442
• Report Number: 8041187-2020-00431
• Device Sequence Number: 825664
• Product Code: FOZ
• UDI-Device Identifier: 30382903812449
• UDI-Public: 30382903812449
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 07/09/2020

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: 03/31/2024
• Device Model Number: 381244
• Device Catalogue Number: 381244
• Device Lot Number: 9080808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/23/2020
• 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