MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER (4F) (SINGLE-LUMEN) (20CM)

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	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "found out there are a total of 3 midlines from the same lot leaking at the insertion site.When they pulled the midline and flushed, examined they did not notice anything wrong with the catheter but they have also been using these for years with no issues.We went through several troubleshooting techniques which we feel this could be med or patient anatomy issues but still want to report.2 exchanged and 1 went to npo meds" this report addresses the first exchanged midline.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz2376 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported "found out there are a total of 3 midlines from the same lot leaking at the insertion site.When they pulled the midline and flushed, examined they did not notice anything wrong with the catheter but they have also been using these for years with no issues.We went through several troubleshooting techniques which we feel this could be med or patient anatomy issues but still want to report.2 exchanged and 1 went to npo meds" this report addresses the first exchanged midline.Additional info.Received 05/11/2022."at what point during device use was the leak discovered (i.E.Insertion, infusion, removal)was the catheter fracture internal to the patient or external?infusion.2.What was infusion when the leak was discovered? meropenum.3.Any patient symptoms related to fluid leak? no.4.Was the catheter removed? was a new catheter placed? yes and yes.5.What type of catheter securement was utilized? statlock.6.A detailed description of the event: 7.What type of catheter securement was utilized? midline.8.Date of occurrence: 4/21 first line replaced with another midline.9.Placement date: 4/11.10.Explant date: unsure do to patient being outpatient and home care was managing line.1.Was there any patient harm reported? no".
Additional Manufacturer Narrative
(h) 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.

• Brand Name: BARD POWERMIDLINE CATHETER (4F) (SINGLE-LUMEN) (20CM)
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14383943
• Report Number: 3006260740-2022-01749
• Device Sequence Number: 20488279
• Product Code: PND
• UDI-Device Identifier: 00801741141126
• UDI-Public: (01)00801741141126
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: CK000756
• Device Lot Number: REFZ2376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown