MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redr1867 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that while " conducting 3cg training the line separated from hub while still inserted in patient causing line having to be removed and replaced to continue therapy." addendum per received email 01/28/2020 - placement info: line was placed in l basilic vein using mst.No complications noted during insertion.Pt is alert and oriented without confusion.Indicated they were just lying in bed and noticed that the hub of the catheter had come undone.Was there patient harm reported?: no.

Manufacturer Narrative

H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged midline catheter was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 3fr s/l provena midline catheter.Usage residues were observed throughout the sample.The sample was received in two segments which shared a complete break at the tubing/luer joint.Microscopic inspection of the break site revealed a granular fracture surface.Beach marks were observed throughout a majority of the fracture surface.Gaps were observed in the joint between the tubing and the luer adapter.The beach marks and material flow suggested that tubing breakage originated at those gaps.The gaps in the bonding between the luer adapter and extension tubing appeared to have caused or contributed to the observed material failure.It appeared those gaps occurred during the manufacturing process.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.Reynosa evaluation: complaint due to ¿line separated from hub¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual performed at vad lab the following was concluded: the gaps between the luer hub and extension tubing appeared to have caused or contributed to the reported detachment line.This kind of defect could be caused during the molding process at supplier facility.Therefore, the cause of this condition is supplier related.An incident report was issued to notify our supplier about this issue.A lot history review (lhr) of redr1867 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that while " conducting 3cg training the line separated from hub while still inserted in patient causing line having to be removed and replaced to continue therapy." addendum per received email (b)(6) 2020 - placement info: line was placed in l basilic vein using mst.No complications noted during insertion.Pt is alert and oriented without confusion.Indicated they were just lying in bed and noticed that the hub of the catheter had come undone.Was there patient harm reported?: no.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9702354
• MDR Text Key: 196575215
• Report Number: 3006260740-2020-00503
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S4153108BDP
• Device Lot Number: REDR1867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR