MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER MIDLINE CATHETER 4F SL; CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
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 reds1161 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "the kit was opened, cannulated vein with access needle and wire.Went to tighten (screw down) dilator on micro ez introducer prior to placement, picked introducer up and a scrap of wire fragment fell out of dilator onto sterile field.No patient injury noted.".
Additional Manufacturer Narrative
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 wire fragment present within the introducer is inconclusive due to poor sample condition.One 50 cm guidewire, one stylet t lock assembly, and one 4.5 fr microez microintroducer were returned for investigation.A product label sticker was returned with lot: reds1161.The guidewire was passed through the dilator and no wire material fragment was present within the shaft.Microscopic observation of the distal ends of the guidewire and stylet revealed them both to be intact.Since a wire fragment was not observed and the returned wires did not appear to be frayed, the complaint is inconclusive.A lot history review (lhr) of reds1161 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "the kit was opened, cannulated vein with access needle and wire.Went to tighten (screw down) dilator on micro ez introducer prior to placement, picked introducer up and a scrap of wire fragment fell out of dilator onto sterile field.No patient injury noted.".

• Brand Name: POWER MIDLINE CATHETER 4F SL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9234525
• Report Number: 3006260740-2019-03326
• Device Sequence Number: 344128
• Product Code: PND
• UDI-Device Identifier: 00801741140310
• UDI-Public: (01)00801741140310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: CK000523B
• Device Lot Number: REDS1161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1