MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen1144 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reen1144) have been reported from the same facility.
Event or Problem Description
It was reported "i am contacting you again regarding leaking bard power midlines.I know in the past we decided it is not a leak from the product itself, but fluid and blood are leaking out around the product from insertion sites.It was suggested to us to cut the midlines shorter to prevent possible back pressure occurring at the shoulder joint.This suggestion has not helped.If i had to guess, we are replacing 75% of the midlines we place for this leaking issue".Midline was found to be leaking from insertion site.Catheter exterior the body 0.5 cm.Dressing change was attempted earlier in the day.Found to be saturated two hours later.Catheter removed intact.No sign/symptoms of infection noted at insertion site.Patient was switched from iv antibiotics to oral for discharge.What type of catheter securement was utilized? 3m dressing stat lock.
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 midline catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 3fr s/l powermidline catheter.Usage residues were observed throughout the sample and a needleless injection cap was attached to the luer adapter.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.Microscopic inspection of the sample did not reveal any evidence of current or prior leakage.No device deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported "i am contacting you again regarding leaking bard power midlines.I know in the past we decided it is not a leak from the product itself, but fluid and blood are leaking out around the product from insertion sites.It was suggested to us to cut the midlines shorter to prevent possible back pressure occurring at the shoulder joint.This suggestion has not helped.If i had to guess, we are replacing 75% of the midlines we place for this leaking issue." add info rcvd : midline was found to be leaking from insertion site.Catheter exterior the body 0.5 cm.Dressing change was attempted earlier in the day.Found to be saturated two hours later.Catheter removed intact.No sign/symptoms of infection noted at insertion site.Patient was switched from iv antibiotics to oral for discharge.What type of catheter securement was utilized? 3m dressing stat lock.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11530929
• Report Number: 3006260740-2021-00895
• Device Sequence Number: 4091074
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: REEN1144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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: 82 YR
• Patient Weight: 84