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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refx5389 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "during the peeling the orange handle fractured off the grey sheath halfway through the peeling process.The proceduralist had to pull the midline and sheath back to continue to remove the sheath from around the midline with her fingers.".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a detached sheath is confirmed but the exact cause remains unknown.One 4.5 fr x 5 cm microez microintroducer was returned for evaluation.The sheath was returned fully peeled.One of the peel tabs was detached from the proximal end of the sheath material.Microscopic observation of the peel tab revealed a slot in the inner portion of the peel.The presence of the slot suggests the sheath was attached to the tab during manufacture of the device.A non-complainant sample was inspected.A tensile/upward force was applied during peeling to the non-complainant sample which resulted in detachment of the sheath from the tab.The characteristics of the non-complainant sample resembled the characteristics of the returned sample.Based on the characteristics of the sheath and tab, likely contributing factors include application of a tensile force during peeling of the sheath.Since the sheath from the returned sample was detached from the tab, the complaint is confirmed; however, the exact factors leading to the detachment remain unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "during the peeling the orange handle fractured off the grey sheath halfway through the peeling process.The proceduralist had to pull the midline and sheath back to continue to remove the sheath from around the midline with her fingers.".

• Brand Name: POWERMIDLINE CATHETER, 4F SL
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14465607
• Report Number: 3006260740-2022-01898
• Device Sequence Number: 4570468
• Product Code: PND
• UDI-Device Identifier: 00801741188084
• UDI-Public: (01)00801741188084
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: CK000799A
• Device Lot Number: REFX5389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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