MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 4F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	CK000589A
Health Effect - Clinical Code	Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of patient numbness was inconclusive because no sample was returned to vad for evaluation.Based on the description of the reported event, possible contributing factors include picc placement technique, nerve damage, non-device related factors, transitory effects of the procedure, and patient condition; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.A lot history review (lhr) of rebv2223 showed no other similar product complaint(s) from this lot number.Device remains in patient.
Event or Problem Description
Per ms&s: spouse states that patient had a powerpicc solo inserted in the left arm.Spouse states that since the powerpicc solo was placed patient left thumb has felt numb.Patient states now the left thumb is totally numb and now the tips of the left fingers are numb.Spouse does not know if the brachial vein was utilized.Spouse states that patient is receiving chemotherapy through the powerpicc solo.Ms&s informed spouse to contact patient's physician concerning the total numbness in the left thumb and numbness in tips of left fingers evaluated.

• Brand Name: POWERPICC SOLO CATHETER, 4F SL, 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: 8076125
• Report Number: 3006260740-2018-03237
• Device Sequence Number: 19175159
• Product Code: LJS
• UDI-Device Identifier: 00801741137624
• UDI-Public: (01)00801741137624
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CK000589A
• Device Lot Number: REBV2223
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization