MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F TL POWERPICC HF 3CG MB; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number CK000539

Device Problems Device Inoperable (1663); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  malfunction  

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 reaw0049 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to the sales rep that the picc malpositioned and stopped working after 12 days and required replacement.No other information was provided, but has been requested.

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 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 into an s-curve.It was reported that the catheter stopped working 12 days after placement, 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 Description

Facility reported to the sales rep that the picc malpositioned and stopped working after 12 days and required replacement.No other information was provided, but has been requested.

• Brand Name: 5F TL POWERPICC HF 3CG MB
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6733671
• MDR Text Key: 80873906
• Report Number: 3006260740-2017-01110
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741105197
• UDI-Public: (01)00801741105197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: CK000539
• Device Catalogue Number: CK000539
• Device Lot Number: REAW0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1