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

Catalog Number	381244
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ peripheral venous catheter contained foreign matter described as "plastic particles".No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
One actual sample in opened packaging was returned for investigation.The actual sample was subjected to visual inspection.No plastic particles were observed on cannula of the returned sample.However, clear, gel-like particle was observed on the cannula tip of the returned sample.The clear, gel-like particle was subjected to fourier transform infrared spectroscopy test.The ftir results showed that the spectrum of the clear, gel-like particle matched the spectrum of silicone and the lubricant used in the manufacturing facility.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.The clear gel-like particle observed was not found to be fm but was actually silicone material, contained in the lubricant used during the lubrication process.The dhr review indicated that the drag force was within specification.Silicone presence on the assembled needles are part of the manufacturing process.
Event or Problem Description
It was reported that bd insyte peripheral venous catheter contained foreign matter described as "plastic particles".No serious injury or medical intervention was reported.

• Brand Name: BD INSYTE¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7843720
• Report Number: 8041187-2018-00301
• Device Sequence Number: 13872875
• Product Code: FOZ
• UDI-Device Identifier: 30382903812449
• UDI-Public: 30382903812449
• 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,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 381244
• Device Lot Number: 8004290
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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