MAUDE Adverse Event Report: 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	04/30/2021
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 reex2151 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the peel away sheath of a midline catheter met resistance at the very end as though it was not perforated resulting in the inability to fully peel it away.
Event or Problem Description
It was reported that the peel away sheath of a midline catheter met resistance at the very end as though it was not perforated resulting in the inability to fully peel it away.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an incomplete split in a microintroducer sheath is confirmed; however, the exact cause is unknown.One 4.5 fr x 7 cm microintroducer and one 4 fr single lumen powermidline catheter were returned for evaluation.An initial visual observation showed use residue on the returned samples.The catheter was found to be inserted into the sheath, which was found to be partially split.The split in the sheath was found to end approximately 4 mm proximal to the distal tip of the sheath.A microscopic observation revealed some whitening of the sheath material on the fracture surface of the split near the distal end of the split.Slight webbing of the sheath material was observed at the corner of one side of the split.The sheath was able to be split the rest of the way with some slight resistance.While the exact cause of the incomplete spilt in the returned sample is unknown, possible contributing factors include storage conditions, material variation, position of catheter during insertion, and patient anatomy.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERMIDLINE CATHETER, 4F SL
• Common Device Name: MIDLINE CATHETER
• MDR Report Key: 11872897
• Report Number: 3006260740-2021-01977
• Device Sequence Number: 3663421
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: CK000799A
• Device Lot Number: REEX2151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 09/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: 50 YR