MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY); CATHETER, PERCUTANEOUS

Catalog Number 7715435CE

Device Problem Device Operates Differently Than Expected (2913)

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

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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported: "impossibility of perfusion, poorly perforated catheter at its extremity.Need to rest a second midline." no patient injury reported.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend 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 poorly functioning catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l groshong midline catheter.The returned catheter segment included the distal tip through the 25cm depth marking.No connector was returned.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed near the 24cm depth marking.Microscopic inspection of the leak site revealed a small diagonally aligned split.The split edges appeared granular.Following longitudinal bisection of the sample in the vicinity of the split, inspection of the internal surface revealed longitudinally aligned scoring marks.The split in the internal surface was more extensive than that in the external surface.No occlusions were observed during device evaluation; however, a split in the catheter tube was discovered.Catheter damage prevents proper catheter function and can lead to blood product occlusion.The split characteristics and internal scoring marks were consistent with damage caused by contact between the catheter and the inlaid stylet.Such damage can occur if the catheter is not flushed prior to stylet removal and if the catheter is compressed or bent during stylet removal.The product ifu states ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported: "impossibility of perfusion, poorly perforated catheter at its extremity.Need to rest a second midline." no patient injury reported.

• Brand Name: GROSHONG MID LINE MINI TRAY 4F (EXPORT ONLY)
• Type of Device: CATHETER, PERCUTANEOUS
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7476453
• MDR Text Key: 107154293
• Report Number: 3006260740-2018-00863
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7715435CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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