MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR DL POWERMIDLINE FULL KIT; MIDLINE CATHETER

Catalog Number	P4254108
Health Effect - Clinical Codes	Death (1802); Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Death
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 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 catheter leak and that the catheter extended to the 15cm mark at the time of insertion and was only 5 ½ cm in length at the time of removal was inconclusive due to the sample condition.Three photographs were the only items provided for investigation.The first photograph showed the distal end of the bifurcation and the d/l catheter tubing extending to a point between the 5 and 6 cm depth marks, where it terminated.The remainder of the catheter was not shown in the photo.What appeared to be a copy of the label was observed underneath the catheter.The product code and lot number were p4254108 and rebx1288, respectively.The 2nd photograph showed the catheter between the 1cm depth mark and the distal tip beyond the 5cm depth mark.The 3rd photo showed the overall catheter, which included the connectors, extension legs, bifurcation and d/l catheter, which extended to a point between the 5 and 6 cm depth marks.Without the physical sample or a detailed image of the distal end of the catheter tubing, it could not be determined how or when the catheter was segmented.The catheter was reportedly placed on (b)(6) 2018.An x-ray on (b)(6) 2018 showed the catheter intact.The catheter was reportedly leaking on (b)(6) 2018.The patient died on (b)(6) 2018 and the cause of death was reportedly due to terminal wean off of a ventilator.That the implicated product caused or contributed to the patient death was undetermined.A review of the manufacturing records revealed no evidence to support that the reported event was associated with a deficiency in product manufacture; therefore no further action will be taken at this time.A lot history review (lhr) of rebx1288 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a nurse placed a powermidline in a patient on (b)(6)2018 that was cut to 15cm prior to insertion.On (b)(6) 2018 the patient had a chest x-ray which showed an intact catheter.On (b)(6) 2018 the patient had another chest x-ray and the catheter was not seen.The catheter began leaking and on (b)(6) 2018 the same nurse that placed the catheter performed an over the wire transfer to replace it.Once removed, the catheter was noted to only be 5 1/2 cm in length from the zero mark.X-rays, ct scans and fluoroscopy were performed to locate the broken piece of catheter, however, it was not found in the patient.It was noted that the tip of the removed piece of catheter is smooth and at an angle.It was also reported that the patient expired (b)(6) 2018 due to terminal wean off of a ventilator.

• Brand Name: 4FR DL POWERMIDLINE FULL KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7308224
• Report Number: 3006260740-2018-00322
• Device Sequence Number: 1342528
• Product Code: PND
• UDI-Device Identifier: 00801741129278
• UDI-Public: (01)00801741129278
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: P4254108
• Device Lot Number: REBX1288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death