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

Catalog Number	381344
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while a nurse was attempting to remove a bd insyte ¿ iv catheter winged, it seemed to stick inside the vein making it difficult to remove.An anesthetist extracted it finding ¿white traces¿ of glue on the catheter.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: 1 used actual sample and 1 unused representative sample were returned for investigation.Device history record of packaged needle (pn) batch 7139088, catalogue number 381344 and its assembled needle (an) batches 7111390 and 7139120, part number 8083545 was reviewed.No quality notification was raised for similar nonconformance during the production of this batch.Figure: returned samples.Both samples were subjected too visual inspection.No abnormalities were observed on both returned samples.Figure: no abnormalities observed.The oily substances on the surface of both catheters were subjected to fourier transform infrared spectroscopy test.The ftir results showed that the oily substance of the actual sample (sample in zip lock bag) had matched the catheter solvent used in the manufacturing facility.The ftir results showed that the oily substance of the representative sample (sample in unit package) had matched the catheter solvent used in the manufacturing facility.The nonconformance cannot be confirmed as the oily substances from both returned samples had matched with the catheter lubricant used in the manufacturing facility.Investigation conclusion: the root cause cannot be determined as the oily substances from both returned samples had matched with the catheter lubricant used in the manufacturing facility.

• Brand Name: BD INSYTE ¿ IV CATHETER WINGED
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7298152
• Report Number: 8041187-2018-00034
• Device Sequence Number: 1847212
• Product Code: FOZ
• UDI-Device Identifier: 30382903813446
• UDI-Public: 30382903813446
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: Nurse
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 381344
• Device Lot Number: 7139088
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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