MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 4 FR SL WITH SHERLOCK 3CG STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number 1194118

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaw0723 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.

Event Description

It was reported that picc inserted (b)(6) 2017, and removed (b)(6) 2017, due to a kink in the catheter.No patient injury was reported.

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 kink in the catheter was confirmed, but the exact cause is unknown.One radiographic image was returned for investigation.The image showed the thoracic region.What appeared to be a catheter was visible on what was indirectly referred to as the right side of the patient.The words ¿picc placement¿ were positioned above the image of the catheter.The catheter appeared to be kinked and tightly curled at the point it descended downward.At this time, based on the evidence provided with the returned sample, it is unknown what caused the catheter to kink.It is possible that complications associated with the insertion technique, the clinical setting, and/or vascular structure of the patient were contributing factors in the event.From the evidence provided for investigation, no damage or defects associated with the manufacturing process could be discerned.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.

Event Description

It was reported that picc inserted (b)(6) 2017, and removed (b)(6) 2017, due to a kink in the catheter.No patient injury was reported.

• Brand Name: POWERPICC SOLO 4 FR SL WITH SHERLOCK 3CG STYLET
• 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: 6685789
• MDR Text Key: 79141744
• Report Number: 3006260740-2017-00968
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034527
• UDI-Public: (01)00801741034527
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 1194118
• Device Catalogue Number: 1194118
• Device Lot Number: REAW0723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/02/2017
• 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