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
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006260740-2020-20885
• Device Sequence Number: 14551979
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 118