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

Catalog Number	381211
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2018
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 and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found in the bd insyte¿ iv catheter.There was no report of exposure, injury, or medical intervention.
Event or Problem Description
It was reported that foreign matter was found in the bd insyte iv catheter.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
3 photos were returned for investigation.Fm was observed in the returned photos.1 actual sample in opened packaging was returned for investigation.The sample was subjected to visual inspection.Embedded orange particle was observed in the needle cover of the returned sample.The orange particle was subjected to fourier transform infrared spectroscopy (ftir) test.The result of the test shows that the particle had no good match, but had best matched with protein and polysulfide-based material.Polysulfide is a class of polymers with alternating chains of sulfur atoms and hydrocarbons.Most proteins will have similar spectrums.Thus, it is difficult to ascertain which particular type of protein was detected.The orange particle was found embedded in the needle cover.The needle cover was produced by the supplier.Dhr review of packaged needle batch 4296290 catalogue number 381211 and its assembled needle batch 4297157 catalogue number 8301319 shows no quality notification was raised for similar nonconformance during the production of this batch.There was a corrective action (b)(4) to implement a vacuum suction method to transfer the virgin material into the material tote with cover and seal to minimize the exposed area to prevent any foreign material to drop in.The affected batch was produced before the implementation of the above corrective action.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8005744
• Report Number: 8041187-2018-00382
• Device Sequence Number: 148738
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

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: 10/31/2019
• Device Catalogue Number: 381211
• Device Lot Number: 4296290
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 12/11/2018
• 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