MAUDE Adverse Event Report: BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381123
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 2 bd angiocath¿ iv catheters' needles were difficult to retract during use.The following information was provided by the initial reporter, translated from chinese to english: "it is difficult to withdraw the needle core during use.".
Event or Problem Description
It was reported that 2 bd angiocath¿ iv catheters' needles were difficult to retract during use.The following information was provided by the initial reporter, translated from chinese to english: "it is difficult to withdraw the needle core during use.".
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: (b)(6) 2021.H.6.Investigation: bd received a 22 gauge angiocath unit from lot 7300969 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no physical/mechanical damage to the device that could have caused or contributed to the reported defect.However, during an attempt to retract the needles it failed to retract properly.Based off the visual inspection and testing the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that was caused by a bend in the needle preventing the device from retracting completely.The defect originating during the manufacturing process and maintenance had to be performed on the manufacturing machine.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12021722
• Report Number: 9610048-2021-00096
• Device Sequence Number: 17245330
• Product Code: FOZ
• UDI-Device Identifier: 30382903811237
• UDI-Public: 30382903811237
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/09/2021

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: 10/31/2022
• Device Model Number: 381123
• Device Catalogue Number: 381123
• Device Lot Number: 7300969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1