MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	CK000502
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 17mb9741 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility, via the sales rep, that they requested a triple and they opened the kit and the picc was "defective", they stated the hub was cracked and only had dual lumens left.They stated the nurse was okay with that as existing right cephalic picc is a midline and can be used as third access.On (b)(6) 2017-per sales rep: event was noticed upon opening.Device was not placed.
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 luer connector was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was a 6fr t/l powerpicc solo catheter.The sample was returned with the 3cg lead still inserted through the red luer and the sample appeared clean and unused.The white solo connector cap contained a single longitudinally-aligned crack in the white luer connector cap.Further examination showed that a segment of the luer threads on the same connector was broken from the connector and was not returned for evaluation.The crack was then forced open in order to inspect the inner fracture surface.Microscopic examination of the fracture surfaces found that it was rough and granular in nature and topographically complex.An investigation has been opened regarding complaints of this issue type.This device was manufactured prior to the associated corrective actions.Corrective actions are being implemented to prevent recurrence of this event.A lot history review (lhr) of 17db8618 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility, via the sales rep, that they requested a triple and they opened the kit and the picc was "defective", they stated the hub was cracked and only had dual lumens left.They stated the nurse was okay with that as existing right cephalic picc is a midline and can be used as third access.08/23/2017-per sales rep: event was noticed upon opening.Device was not placed.

• Brand Name: BARD MYPICC KIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6844576
• Report Number: 3006260740-2017-01539
• Device Sequence Number: 10778211
• Product Code: LJS
• UDI-Device Identifier: 00801741098840
• UDI-Public: (01)00801741098840
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 06/30/2018
• Device Model Number: CK000502
• Device Catalogue Number: CK000503
• Device Lot Number: 17DB8618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR