MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4F SL POWERPICC 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	CK000537
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 the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaz1009 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the picc was placed in the right basilic, arm circ 35cm, picc 35 cm long/0 out ¿ cxr verification @ mid to lower svc (2-3cm from caj).The rn stated there was issues for several days prior to exchange and had cathfloed it.On the 7th day it completely stopped working.When they called me 7 days after placement i asked for a cxr.Tip was very proxmal svc (8cm from caj) original dressing still intact, picc remains 0 cm out.Picc was exchanged.No patient injury was reported.
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 the picc malposition within the arm was confirmed, but the exact cause was unknown.One radiographic image was provided for investigation.The image was labeled ¿right¿ and showed what appeared to be a picc in the upper arm area.The image provided a point of view that made the catheter appear folded back on itself in two locations.Each section that appeared to be folded back on itself exhibited varying contrast and brightness.The depth and curvature of the catheter in this region was indistinguishable.It was reported that the catheter stopped working on the 7th day, which could be attributable to the malposition.Any images taken at the time of placement were not provided for investigation.Based on the evidence provided for investigation, the exact cause is unknown.No other similar complaints with this lot were reported from other facilities.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.Potential contributing factors include insertion technique, patient anatomy, and patient movement.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
Facility reported to the sales rep that the picc was placed in the right basilic, arm circ 35cm, picc 35 cm long/0 out ¿ cxr verification @ mid to lower svc (2-3cm from caj).The rn stated there was issues for several days prior to exchange and had cathfloed it.On the 7th day it completely stopped working.When they called me 7 days after placement i asked for a cxr.Tip was very proxmal svc (8cm from caj) original dressing still intact, picc remains 0 cm out.Picc was exchanged.No patient injury was reported.

• Brand Name: 4F SL POWERPICC 3CG MB
• 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: 6733115
• Report Number: 3006260740-2017-01107
• Device Sequence Number: 1490336
• Product Code: LJS
• UDI-Device Identifier: 00801741105173
• UDI-Public: (01)00801741105173
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2017

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: 02/28/2018
• Device Model Number: CK000537
• Device Catalogue Number: CK000537
• Device Lot Number: REAZ1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1