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

Catalog Number	381234
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8136482, medical device expiration date: 2023-05-31, device manufacture date: 2018-05-16.Medical device lot #: 8300582, medical device expiration date: 2023-10-31, device manufacture date: 2018-10-27.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 the cannula of a bd¿ insyte was pierced through by catheter needle.Foreign complaints the following information was provided by the initial reporter, translated from french to english: "when opening the package, once the catheter has been uncapped, the nurse realizes that the cannula is transfixed by the catheter needle.The catheter is not usable.".
Event or Problem Description
It was reported that the cannula of a bd¿ insyte was pierced through by catheter needle.Foreign complaints the following information was provided by the initial reporter, translated from french to english: ¿ when opening the package, once the catheter has been uncapped, the nurse realizes that the cannula is transfixed by the catheter needle.The catheter is not usable.¿.
Additional Manufacturer Narrative
Investigation: dhr was reviewed and no quality notification was raised related to the complaint.No sample or photo was received so the complaint in unconfirmed.Needle pierced through catheter could have occurred during assembly of catheter and cannula or during product application when the product was manipulated.Capa#590840 has been initiated to address the issue.

• Brand Name: BD¿ INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8487810
• Report Number: 8041187-2019-00283
• Device Sequence Number: 16575118
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• 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,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: Health Professional
• Device Catalogue Number: 381234
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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