MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	F118080T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "upon pulling back on device housing to safety with right hand while holding wings steady with left hand the needle separated from the housing." there was no impact to the patient.No other information was provided.
Additional Manufacturer Narrative
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of detached powerglide pro introducer needles was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was 16 18ga x 8cm powerglide pro midline catheter assemblies.15 samples were received in their original sealed packaging.The remaining sample was received with its original opened packaging but appeared to have been manipulated.The catheter had been advanced and the safety mechanism was engaged over the needle tip.The catheter was not returned.The needle shaft was completely detached from the housing.The green plastic collar remained within the housing.The 15 sealed samples were opened.The catheters were advanced and the safety mechanisms were engaged.The first 14 samples functioned as intended.When testing the 15th sample, the needle easily detached from the green collar during safety activation.Microscopic inspection of the two detached needles revealed adhesive residue on the portion of the needle intended to be bonded to the green collars.Inspection of the green collars revealed them to appear well-formed.The two observed needle detachments appeared to be caused by failure of the bond between the needles and the needle collars.Such failure may be caused by insufficient adhesive applied and insufficient curing of applied adhesive during device assembly.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer "upon pulling back on device housing to safety with right hand while holding wings steady with left hand the needle separated from the housing." there was no impact to the patient.No other information was provided.On 10/13/2023, sixteen samples were returned for evaluation.The needle detached easily from the housing on two of the returned samples.This report addresses the first sample with an easily detached needle.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (8CM)
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16613131
• Report Number: 3006260740-2023-00987
• Device Sequence Number: 14685293
• Product Code: FOZ
• UDI-Device Identifier: 00801741142642
• UDI-Public: (01)00801741142642
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 04/30/2024
• Device Catalogue Number: F118080T
• Device Lot Number: REGV1321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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