MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO PNK 20GA X 1.88IN; INTERVASCULAR CATHETER

Catalog Number	392537
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the iag bc pro pnk 20ga x 1.88in experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 392537, batch no: 9262427.It was reported to me that on (b)(6), in one of the bd catheters that was sealed and supposed to be sterile in the package has a long human hair inside.The package was not opened and there was no break in the seal but the hair was inside the packaging, wrapped around the catheter.Catheter type: bd insyte autogard bc pro 20 ga x 1.88in.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/23/2020.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one unused unit within a sealed package from (b)(4), lot 9262427.A device history record review showed no non-conformances associated with this issue during the production of this batch.Through the visual/microscopic examination the unit revealed that a strand of hair was wrapped around the needle cover confirming the reported defect.This was physical/mechanical evidence to confirm and support a manufacturing/ packaging related issue for the reported defect relating to an operator error.
Event or Problem Description
It was reported that the iag bc pro pnk 20ga x 1.88in experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 392537.Batch no: 9262427.It was reported to me that on 11/27, in one of the bd catheters that was sealed and supposed to be sterile in the package has a long human hair inside.The package was not opened and there was no break in the seal but the hair was inside the packaging, wrapped around the catheter.Catheter type: bd insyte autogard bc pro 20 ga x 1.88in.

• Brand Name: IAG BC PRO PNK 20GA X 1.88IN
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11092584
• Report Number: 1710034-2020-00838
• Device Sequence Number: 676180
• Product Code: FOZ
• UDI-Device Identifier: 00382903925377
• UDI-Public: 00382903925377
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 08/31/2022
• Device Catalogue Number: 392537
• Device Lot Number: 9262427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1