MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381454
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: (b)(6) was used as only age was provided.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 prior to use the catheter tip was discovered to be damaged with 2 bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: they refer from the service: "peripheral venous catheter # 16 is uncovered and it is flowered, a new catheter is requested and it is the same." in total, two catheters were identified with the same defect.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed a 16ga unit being held in a gloved hand.The catheter tubing could be seen pushed up above the needle tip.The catheter tubing appears to be longer than the needle.However, part of the catheter adaptor view is obstructed by the gloved fingers holding the unit, which makes it impossible to verify whether the adaptor is properly seated.Moreover, the needle may be partially retracted, but photograph does not capture the whole unit, so it is impossible to verify.A lie distance defect could originate during the needle set to height step from incorrect equipment settings.There is 100% automated vision system inspection that checks the needle height.If the needles are not set to the proper height, grippers grip the needles and adjust their height.Without the actual sample, the lie distance could not be properly measured.The catheter tip was observed to be unacceptable per the observations made from review of the photograph.This type of defect could originate during the tipping process, from insufficient lubrication, damage, or a dirty mandrel.The lubrication flow is monitored by a flow sensor control.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
Event or Problem Description
It was reported that prior to use the catheter tip was discovered to be damaged with 2 bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, translated from spanish to english: they refer from the service: "peripheral venous catheter # 16 is uncovered and it is flowered, a new catheter is requested and it is the same." in total, two catheters were identified with the same defect.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10457904
• Report Number: 1710034-2020-00541
• Device Sequence Number: 3860107
• Product Code: FOZ
• UDI-Device Identifier: 30382903814542
• UDI-Public: 30382903814542
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K952861
• 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,Followup
• Report Date (Section B): 10/08/2020

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: 04/30/2022
• Device Model Number: 381454
• Device Catalogue Number: 381854
• Device Lot Number: 9115980
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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
• Patient Age: 32 YR