MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 3 FR. SINGLE-LUMEN PICC; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number 4133105

Device Problem Material Integrity Problem (2978)

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

Event Date 08/21/2016

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 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 damaged stylet was confirmed, and the cause appears to be use related.A per-q-cath 3 fr single lumen picc was returned for investigation.Images provided for investigation show a translucent glove with what appears to be a per-q-cath picc inside the glove.The red stylet hang tag is visible within one of the fingers.A portion of what appears to be the stylet wire is also curved inside the same finger of the glove.The returned physical sample revealed bends in the catheter between the 12 and 16 cm depth marks.The catheter extended 5mm from the 25cm depth mark.The distance between the distal end of the black stylet pull tab and the proximal end of the septum on the t-lock extension set was 9.3cm.A functional test showed that the picc was patent to infusion.No leaks were detected in the tubing.An attempt was made to remove the stylet from the lumen, but it was noted that the coil wire was stretching over the core wire.The stylet was removed and it was verified that the coil wire was stretching over the core wire of the stylet.A microscopic examination showed that the weld tip was not present on the stylet and the cross sections at the distal tip of the stylet were noted to be flat with striations across a portion of the surface.The striated surface exhibited increased luster compared to the remainder of the cross section.These characteristics indicate that the stylet was severed with a sharp instrument, and most likely occurred when the catheter was trimmed to length.The core wire extended 38.4cm from the black pull tab, which indicates that the stylet was cut approximately 38.6 from the weld tip.The severed end of the stylet most likely remained in the section of the catheter that was trimmed away.The ifu states, ¿retract the stylet to well behind the point the catheter is to be cut.Using a sterile scalpel or scissors, carefully cut the catheter according to institutional policy.Caution: do not cut stylet.¿ the red hang tag on the stylet also states, ¿do not cut stylet ¿ withdraw stylet before trimming catheter¿.The reported damage to the stylet occurred during use of the device.A lot history review (lhr) of rexg0978 showed two other similar product complaint(s) from this lot number.

Event Description

It was reported that during the insertion of catheter picc, the guidewire presented tortuosity.No patient injury reported.

• Brand Name: PER-Q-CATH PLUS 3 FR. SINGLE-LUMEN PICC
• 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: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6328779
• MDR Text Key: 67648871
• Report Number: 3006260740-2017-00075
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844(17)180728(10)REXG0978
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: 4133105
• Device Lot Number: REXG0978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Patient Age: 8 MO