MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM; PISTON SYRINGE

Catalog Number 383319

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2020

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.(b)(4).

Event Description

It was reported that 7 bd saf-t-intima¿ iv catheter safety systems experienced safety mechanism failure during use.The following information was provided by the initial reporter: we had an incident over the weekend when an rpn was inserting the sub q set and when pulling the mechanism back, the needle was exposed and the safety cover did not cover the contaminated needle.We have had incidents like this occur with this produce previously.Would we be able to return this specific lot # and receive new.Lot # 0058447, exp.2024-02-29.We currently have 7 units of the bd saf-t-intima in the building.I do not have a sample that displays the defect.The needle was safely disposed of when the safety mechanism failed.I have 7 units of unopened product with the same lot #.

Event Description

It was reported that 7 bd saf-t-intima¿ iv catheter safety systems experienced safety mechanism failure during use.The following information was provided by the initial reporter: we had an incident over the weekend when an rpn was inserting the sub q set and when pulling the mechanism back, the needle was exposed and the safety cover did not cover the contaminated needle.We have had incidents like this occur with this produce previously.Would we be able to return this specific lot # and receive new.Lot # 0058447, exp.2024-02-29.We currently have 7 units of the bd saf-t-intima in the building.I do not have a sample that displays the defect.The needle was safely disposed of when the safety mechanism failed.I have 7 units of unopened product with the same lot #.

Manufacturer Narrative

H6: investigation summary: a device history record review was completed by our quality engineer team for provided lot number 0058447.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.H3 other text : see h.10.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10714930
• MDR Text Key: 249650767
• Report Number: 9610847-2020-00328
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 383319
• Device Lot Number: 0058447
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1