MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/26/2019
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 redn1563 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during picc placement, introducer was placed over wire but unable to be inserted.Patient experienced discomfort, rn withdrew peel away sheath and observed a blunt tear/notch at the distal end of the peel away sheath, the dilator did not appear to be affected.No patient harm observed other than discomfort.Rn opened a new introducer and picc was placed successfully.
Additional Manufacturer Narrative
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, applicable previous investigation(s), sample analysis, applicable fmea documents, labeling, and applicable manufacturing records.Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed and based on the condition of the returned sample, it appeared that the introducer was damaged during use.One 5fr x 7cm ptfe introducer sheath was returned for investigation.Damage was observed at the distal end of the sheath.The distal edge of the sheath was crumpled.The sheath length was within specification.The undamaged section of the taper at the distal end of the sheath appeared to be properly formed.The sheath was kinked 1.7cm from the distal end of the red tabs.It appears that the kink occurred without the internal support of the dilator.The dilator was not returned for investigation.Blood residue was observed within the crumpled folds of the sheath, which indicates that the sample was used.This type of damage can occur during use when the sheath comes in contact with the surrounding tissue of the insertion site.The sheath and dilator should be advanced together as a unit over the guidewire, using a slight rotational motion.Since the damage was observed on the sheath, the complaint was confirmed.Due to the condition of the sample, it appeared that the damage occurred during use.A lot history review (lhr) of redn1563 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during picc placement, introducer was placed over wire but unable to be inserted.Patient experienced discomfort, rn withdrew peel away sheath and observed a blunt tear/notch at the distal end of the peel away sheath, the dilator did not appear to be affected.No patient harm observed other than discomfort.Rn opened a new introducer and picc was placed successfully.

• Brand Name: POWERPICC SOLO2 FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLE
• 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: 8525125
• Report Number: 3006260740-2019-00908
• Device Sequence Number: 2798377
• Product Code: LJS
• UDI-Device Identifier: 00801741119095
• UDI-Public: (01)00801741119095
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: CK000505A
• Device Lot Number: REDN1563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1