MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT,4FR POWERMIDLINE; MIDLINE CATHETER

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	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by medwatch patient required midline.During midline insertion, peel-away introducer failed to separate properly causing catheter to withdraw.Required introducer to be cut to be removed.No patient harm.No other information was provided.
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 manufacturer has received the sample and will evaluate.Results are expected soon.
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 complaint of difficulty separating the sheath was confirmed and was determined to be manufacturing related.The product returned for evaluation was a 4.5fr microintroducer sheath.Usage residues were observed through the sheath.The orange handle was not evenly split in half near the distal end of the handle.The sheath was observed to be split on one side only.An attempt to continue pulling the sheath apart was successful and no resistance was observed.Microscopic inspection of the orange handle revealed excess material on one side of the handle in the catheter channel which may have prevented removal from the catheter.The excess material on the handle suggested an incomplete skiving process during device manufacture.This complaint will be forwarded to the manufacturing site for further evaluation.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by medwatch patient required midline.During midline insertion, peel-away introducer failed to separate properly causing catheter to withdraw.Required introducer to be cut to be removed.No patient harm.No other information was provided.

• Brand Name: DOT,4FR POWERMIDLINE
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19644965
• Report Number: 3006260740-2024-03414
• Device Sequence Number: 6632817
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761(11)231108(17)250228(10)REHW2961
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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 Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REHW2961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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 Age: 23 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: American Indian Or Alaskan Native