MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24G X 0.56IN (0.7 X 14 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number	381311
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 an unspecified number of 24g x 0.56in (0.7 x 14 mm) insyte experienced product damage.The following information was provided by the initial reporter: at the time of the installation of the device, yellow catheter, during the purge of the catheter, purge is impossible.It is possible to purge the needle and catheter separately but not together.Customer added the following info after question: it is true that in the practices of use of a short catheter, it is not frequent to purge it before use but in neonatology it is purged before puncturing the vein, this is explained by the fact that our patients have a low venous return and this practice facilitates catheter placement.
Event or Problem Description
It was reported that an unspecified number of 24g x 0.56in (0.7 x 14 mm) insyte experienced product damage.The following information was provided by the initial reporter: at the time of the installation of the device, yellow catheter, during the purge of the catheter, purge is impossible.It is possible to purge the needle and catheter separately but not together.Customer added the following info after question : it is true that in the practices of use of a short catheter, it is not frequent to purge it before use but in neonatology it is purged before puncturing the vein, this is explained by the fact that our patients have a low venous return and this practice facilitates catheter placement.
Additional Manufacturer Narrative
Investigation: 3 actual sample was returned for investigation.The sample was subjected to flashback test as per test procedure 80005661.All returned samples passed the flashback test; the sample is not clogged.The complaint is unconfirmed and product is with specification.Dhr was performed and no quality notification was raised for similar nonconformance during the production of this batch.

• Brand Name: 24G X 0.56IN (0.7 X 14 MM) INSYTE
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8549910
• Report Number: 8041187-2019-00326
• Device Sequence Number: 11159682
• Product Code: FOZ
• UDI-Device Identifier: 30382903813118
• UDI-Public: 30382903813118
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8136218
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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