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

Model Number	381234
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: one photo was received by our quality team for evaluation.Upon visual inspection, it was observed that the needle pierced through the catheter.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the investigation, this would have occurred during product application when the product was manipulated or during assembly of catheter.A project has been completed to further address actions required to prevent this incident from occurring during the assembly of the catheter.Customer complaint trends will also continue to be evaluated on a monthly basis.Investigation conclusion: the investigation was able to confirm what customer experienced as needle pierced through catheter was observed on the returned photo.End user risk assessment: severity per p-eura, (b)(4), for needle through catheter is limited (s2) based on the total number of similar complaints received, occurrence (1 / 278,000) x 1,000,000, 3.597 ipm which is remote (o2), the risk is acceptable per ms-qs-034.Root cause description: needle pierced through catheter was observed on the returned photo.This could have occurred during product application when the product was manipulated or during assembly of the catheter.Capa# (b)(4) was raised to address actions required to prevent it from occurring during the assembly of the catheter.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.Rationale: the complaint will be monitored and tracked.
Event or Problem Description
It was reported that the bd insyte¿ iv catheters experienced needle through the catheter during introduction.The following information was provided by the initial reporter: when puncturing a patient with a pink no.16 catheter, the catheter bent with the mandrel also in the vein.(patient in severe pain).Is the incriminated device contaminated with a dangerous product or blood? yes.Did you come into direct contact with blood or a dangerous product during the incident? no.

• 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: 10429460
• Report Number: 8041187-2020-00507
• Device Sequence Number: 2816847
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/06/2020

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: 07/31/2024
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 9216415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/20/2020
• 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