MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN.; INTERVASCULAR CATHETER

Catalog Number 383323

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 22 g x 0.75 in.Experienced safety shield failure.The following information was provided by the initial reporter: material no: 383323; batch no: 8332554 it was reported that the cover did not completely cover the needle, leaving it exposed.Event description states, "cover did not go over end of exposed needle, sharp safety bagged and saved for review.".

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 22 g x 0.75 in.Experienced safety shield failure.The following information was provided by the initial reporter: material no: 383323 batch no: 8332554 it was reported that the cover did not completely cover the needle, leaving it exposed.Event description states, "cover did not go over end of exposed needle, sharp safety bagged and saved for review.".

Manufacturer Narrative

H.6.Investigation: bd was able to verify the reported needle shielding failure after inspecting the provided samples.However, engineering and manufacture team could not confirm or associated the reported defect because, 1 sample received was not activated correctly according with ifu usage recommendation and, 3 samples were received with the complete activated safety device.Three samples with exposed needle were activated manually according ifu, no problems were found during this activation.Reviewed our process, the only way to reproduce this defect is omitting the ifu usage recommendations.Dhr was reviewed and no qn's or other events were found related to the complaint.

Event Description

It was reported that the bd saf-t-intima iv catheter safety system 22 g x 0.75 in.Experienced safety shield failure.The following information was provided by the initial reporter: material no: 383323 batch no: 8332554 it was reported that the cover did not completely cover the needle, leaving it exposed.Event description states, "cover did not go over end of exposed needle, sharp safety bagged and saved for review.".

Manufacturer Narrative

Per additional information, the patient age and gender have been updated.The following information has been corrected: a.2.Age at time of event: 61 years.A.3.Sex: female.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 22 G X 0.75 IN.
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8527517
• MDR Text Key: 142495417
• Report Number: 9610847-2019-00309
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 383323
• Device Lot Number: 8332554
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR