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

Catalog Number P4254108D

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs2614 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported midline was spilt at suture wing and was leaking.The midline was removed.

Event Description

It was reported midline was spilt at suture wing and was leaking.The midline was removed.

Manufacturer Narrative

The information provided by bd 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 bd.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 leak was confirmed but the exact cause remains unknown.One 4 fr dl powermidline catheter and one photo sample were returned for investigation.The sample shown in the photo contained the same characteristics as the returned sample.The catheter extended up to the 13 cm depth marker.Use residue was observed throughout the sample.The wings at the bifurcation hub were observed to be split.The splits were observed to be uneven.The sample was flushed with water using a 12 ml syringe and a leak was observed at the damaged location when flushing the red lumen.Microscopic observation of the split surfaces revealed the splits to be rough and granular.The splits appeared to have propagated at an angle.The internal surface of the damaged area was divided into two splits.One of the splits was observed to extend into the catheter lumen junction.Based on the condition of the returned sample, possible contributing factors include excessive manipulation, securement technique, sharp instrument damage.Since the leaks was confirmed to originate due to damage present on the winged hub, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of recs2614 showed no other similar product complaint(s) from this lot number.

• Brand Name: 4FR DL POWERMIDLINE MAX KIT
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8437276
• MDR Text Key: 139536867
• Report Number: 3006260740-2019-00610
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741129353
• UDI-Public: (01)00801741129353
• Combination Product (y/n): N
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P4254108D
• Device Lot Number: RECS2614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1