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

Catalog Number	CK000723
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 manufacturer has received a photo sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebn1525 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the grey hub cracked on the catheter.No other information was provided.
Additional Manufacturer Narrative
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 a cracked hub is confirmed to be manufacturing related.Two photo samples were returned to vad for observation.One photo consisted of a syringe attached to a grey and blue solo hub.A longitudinal crack was observed to extend from the proximal end of the luer down to the ¿no ct¿ letters in the grey portion of the hub.The characteristics of the break surface could not be clearly observed.The second photo was the product label for a powerpicc provena catheter with solo valve technology with ref: ck000723 and lot: rebn1525.The characteristics of the cracks in the photo are consistent with a known issue, therefore, the complaint is confirmed as manufacturing related.Reynosa evaluation: the complaint for ¿catheter hub crack¿ is confirmed according to the photo evaluation which showed a break in the molding gray valve, maybe those are caused by the incorrect molding process, leading to valve breakage.This condition cause leak in the device.Therefore the cause for this complaint is manufacturing related.A lot history review (lhr) of rebn1525 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the grey hub cracked on the catheter.No other information was provided.
Additional Manufacturer Narrative
The manufacturer has received a photo sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebn1525 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the grey hub cracked on the catheter.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER, 5F TL, TT, 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: 7589155
• Report Number: 3006260740-2018-01325
• Device Sequence Number: 13897068
• Product Code: LJS
• UDI-Device Identifier: 00801741137679
• UDI-Public: (01)00801741137679
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2018

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 Catalogue Number: CK000723
• Device Lot Number: REBN1525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/17/2018; 07/12/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 06/29/2018; 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1