MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F DL FT 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2020
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 20bbo987 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported clinician said she felt the picc hard a rough surface and bumps on it.The device was not used on a patient.
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 a damaged catheter is confirmed but the exact cause remains unknown.One 5 fr dl powerpicc solo catheter was returned for investigation.The 3cg stylet t lock assembly was returned within the catheter.Tactile evaluation of the catheter shaft revealed a rough surface at the 31 cm depth marker.Microscopic observation of the catheter surface revealed material surface damage at the abrasive region.The damaged longitudinal regions were split into three sections.The edges of the damaged regions showed material whitening and were observed to be narrow and higher than the surrounding material.The damage may have been caused by compression by an instrument.The catheter was cut distal to the damaged region in order to observe the position of the lumen relative to the damage.The event description indicates the damage was discovered prior to use; however, the exact the condition of the device out of the package is unknown.Photos of the sample will be forwarded to the manufacturing facility for further evaluation.Reynosa evaluation complaint due to ¿picc has rough surface and bumps on it¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and evaluation performed at vad lab the following was concluded: longitudinal abrasive marks were found to be on the shaft tubing.The edges of the damage regions showed material whitening and appeared to be caused with an instrument.Damage during the manufacturing process may be a potential root cause/contributor to the observed catheter damage.However, based in fg lot 20bbo987 where sa0728432 lots redr0973, reds0018, redt1242 & redz3397 were issued, no findings from the dhr review indicated a manufacturing/processing related event.Possible contributions factors include: risks of damage during packaging, handling or use, etc.Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown.A lot history review (lhr) of 20bbo987 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported clinician said she felt the picc hard a rough surface and bumps on it.The device was not used on a patient.

• Brand Name: POWERPICC SOLO CATHETER 5F DL FT 3CG
• 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: 10175477
• Report Number: 3006260740-2020-02142
• Device Sequence Number: 19424781
• Product Code: LJS
• UDI-Device Identifier: 00801741163265
• UDI-Public: (01)00801741163265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000415C
• Device Lot Number: 20BBO987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1