MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number S4153108D

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

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 reen1144 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported a midline was placed by an imaging services rn and the infusion center found this line to be leaking.The patient was sent to a different facility for evaluation and replacement as needed.Following assessment of the line, it was determined that a new midline was needed and placed by an imaging services rn.No patient harm was reported.

Event Description

It was reported a midline was placed by an imaging services rn and the infusion center found this line to be leaking.The patient was sent to a different facility for evaluation and replacement as needed.Following assessment of the line, it was determined that a new midline was needed and placed by an imaging services rn.No patient harm was reported.

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 leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 3fr s/l provena powermidline midline catheter.Usage residues were observed throughout the sample.Microscopic inspection of the sample did not reveal any damage or evidence of leakage.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.

• Brand Name: 3FR SL PROVENA MIDLINE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10995378
• MDR Text Key: 221546710
• Report Number: 3006260740-2020-20885
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (y/n): N
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S4153108D
• Device Catalogue Number: S4153108D
• Device Lot Number: REEN1144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 118