MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W IV CATHETER WITH WINGS 22GA 1.00IN; INTRAVASCULAR CATHETER

Model Number	381323
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd insyte-w¿ iv catheter with wings 22ga 1.00in had the needle through the catheter.The following information was provided by the initial reporter: "it seems that on several occasions, the needle would have pierced the cannula after a back and forth.".
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: 8/3/2020.H.6.Investigation: three samples were received by our quality team for evaluation.From the returned samples, a needle pierced through the catheter was observed on one sample, catheter damage was observed on one sample, and no abnormalities were observed on one sample.The investigation was able to confirm what the customer had experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, this would have occurred during product application when the product was manipulated or during assembly of catheter.A project, capa#590840, has been completed to further address actions required to prevent this incident from occurring during the assembly of the catheter.
Event or Problem Description
It was reported that bd insyte-w¿ iv catheter with wings 22ga 1.00in had the needle through the catheter.The following information was provided by the initial reporter: "it seems that on several occasions, the needle would have pierced the cannula after a back and forth.".

• Brand Name: BD INSYTE-W IV CATHETER WITH WINGS 22GA 1.00IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10359666
• Report Number: 8041187-2020-00452
• Device Sequence Number: 3552357
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: 30382903813231
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 09/30/2024
• Device Model Number: 381323
• Device Catalogue Number: 381323
• Device Lot Number: 9279953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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