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

Catalog Number	381334
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
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 before use of the bd insyte¿ iv catheter the needle was through the catheter before opening the package.There were six occurrences.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: it was found needle through catheter before opening the package.
Event or Problem Description
It was reported that before use of the bd insyte¿ iv catheter the needle was through the catheter before opening the package.There were six occurrences.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: it was found needle through catheter before opening the package.
Additional Manufacturer Narrative
Investigation: 2 actual samples without unit package were returned for investigation.The samples were not decontaminated.Needle pierced through catheter was observed on the returned samples.The complaint is confirmed and the product is out of specification.Needle pierced through catheter could have occurred during assembly of catheter and cannula or during product application when the product was manipulated.Capa#(b)(4) had been initiated to address needle pierced through catheter issue dhr was completed and no qn was raised for catheter pierced through catheter.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8560601
• Report Number: 8041187-2019-00330
• Device Sequence Number: 2207556
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 381334
• Device Lot Number: 8136225
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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