MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 3F SINGLE-LUMEN MIDLINE WITH SAFETY INTRODUCER INTERMEDIATE TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recv1880 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the midline was broken/leaking.On (b)(6) 2019: it was reported that the patient was prepped for midline placement, went to prime/flush catheter in sterile kit, noticed leaking w/prime.Never used, put to side for report.
Event or Problem Description
It was reported that the midline was broken/leaking.(b)(6) 2019: it was reported that the patient was prepped for midline placement, went to prime/flush catheter in sterile kit, noticed leaking w/prime.Never used, put to side for report.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed, but the exact cause could not be determined.One 3fr single lumen per-q-cath midline was returned for investigation.The stylet and t-lock assembly were attached to the catheter.A functional test revealed fluid leaking through a 0.5mm longitudinal split that was observed in the external surface of the tubing at the distal end of the taper in the molded hub.After removing the stylet, the catheter was bisected near the leak site.A microscopic observation revealed that the damage within the catheter was greater than what was observed on the external surface of the tubing.Impressions from the stylet coil wire were visible at each end of the split.A slight bend was observed in the stylet that coincided with the catheter leak site.It appears that the catheter was compressed against the stylet wire, but how and when this damage occurred could not be determined.The product ifu states, ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.¿ manipulation of the stylet within the lumen can also damage the catheter if the stylet is not wetted prior to repositioning.The ifu indicates to never use force to remove stylet.Resistance can damage the catheter.A review of the manufacturing records showed that no problems were identified during the manufacturing process.A lot history review (lhr) of recv1880 showed no other similar product complaint(s) from this lot number.

• Brand Name: PER-Q-CATH PLUS 3F SINGLE-LUMEN MIDLINE WITH SAFETY INTRODUCER INTERMEDIATE TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8617313
• Report Number: 3006260740-2019-01409
• Device Sequence Number: 18927599
• Product Code: LJS
• UDI-Device Identifier: 00801741074936
• UDI-Public: (01)00801741074936
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K954422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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 Model Number: N/A
• Device Catalogue Number: 4143202
• Device Lot Number: RECV1880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1