MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERMIDLINE¿ CATHETER, 4F SL 20CM; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redx0084 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 "the regular kits we get from you all have the orange winged introducers in them.The "custom" kits we get all have this yellow winged one.The other issue i was addressing is the area where the sheath and the center piece meet near the tip.I've had a few of them where there were "petals" of gray extending over the green piece.You can see this in a couple of the images i've attached.These petals, once you press the gray part into the patient's skin, have a tendency to fold back and make it hard to advance the introducer.".
Event or Problem Description
It was reported "the regular kits we get from you all have the orange winged introducers in them.The "custom" kits we get all have this yellow winged one.The other issue i was addressing is the area where the sheath and the center piece meet near the tip.I've had a few of them where there were "petals" of gray extending over the green piece.You can see this in a couple of the images i've attached.These petals, once you press the gray part into the patient's skin, have a tendency to fold back and make it hard to advance the introducer".
Additional Manufacturer Narrative
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 a damaged microintroducer is confirmed; however, the exact cause is unknown.Two photographs of a galt microintroducer were returned for evaluation.An initial visual observation of the photographs showed the distal tip of the introducer sheath was damaged with the edges plastically deformed and flared outward.One edge of the distal tip of the dilator could be seen to be damaged and flaring outward.No obvious evidence of use could be seen on the sample in either photograph.While the root cause of the damage observed on the introducer sheath in the returned photographs is unknown, possible causes include damage during handling or use.A lot history review (lhr) of redx0084 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

• Brand Name: POWERMIDLINE¿ CATHETER, 4F SL 20CM
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10027005
• Report Number: 3006260740-2020-01645
• Device Sequence Number: 2986591
• Product Code: PND
• UDI-Device Identifier: 00801741159787
• UDI-Public: (01)00801741159787
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000856
• Device Lot Number: REDX0084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1