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

Catalog Number	381311
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 bd insyte-n¿ iv catheter tip was damaged and did not allow liquid to flow through it during use.Tests performed on the device confirmed the catheter was clogged, as the purge with "nacl" did not work, and liquid came out at the level of the screw thread rather than at the level of the bevel.The following information was provided by the initial reporter, translated from (b)(6) to english: bevelled end does not work, the liquid cannot flow.Consequences: healthcare workers cannot make a reflux, catheter not usable.Tests done on different catheters: we notice the catheter is clogged.Purge with nacl does not work.For the same batch some catheters are clogged and others are working properly.Before placing the catheter the nurse purges the catheter with nacl.It can be seen that the liquid comes out at the level of the screw thread.Not at the level of the bevel.Visually the bevel is normal.
Event or Problem Description
It was reported that the bd insyte-n¿ iv catheter tip was damaged and did not allow liquid to flow through it during use.Tests performed on the device confirmed the catheter was clogged, as the purge with "nacl" did not work, and liquid came out at the level of the screw thread rather than at the level of the bevel.The following information was provided by the initial reporter, translated from french to english: bevelled end does not work, the liquid cannot flow.Consequences: healtcare workers cannot make a reflux, catheter not usable.Tests done on different catheters: we notice the catheter is clogged.Purge with nacl does not work.For the same batch some catheters are clogged and others are working properly.Before placing the catheter the nurse purges the catheter with nacl.It can be seen that the liquid comes out at the level of the screw thread.Not at the level of the bevel.Visually the bevel is normal.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the returned units and could not identify any manufacturing related defects.A device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.As a result, the root cause of the reported issue could not be determined.

• Brand Name: BD INSYTE-N¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8565483
• Report Number: 8041187-2019-00333
• Device Sequence Number: 13524215
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 10/31/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8300637
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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