MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG PICC SHERLOCK TIP LOCATION SYSTEM 3F S/L BASIC TRAY; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 9755305

Device Problems Material Frayed (1262); Kinked (1339)

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

Event Date 08/25/2017

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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of reaw0789 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to the sales rep that after the procedure, the wire came out kinked, sheared and appeared frayed.Nurse noted some of the copper coating had been stripped off exposing the inner layer blue wire.No patient injury was reported.

Manufacturer Narrative

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 broken stylet is confirmed and was determined to be use related.One tls stylet was returned for evaluation.An initial visual observation showed the stylet was curled and tangled on itself and bent in several locations.The distal tip of the stylet was observed to be missing and approximately 3 cm of the coated core wire was observed to be exposed.A microscopic observation revealed the stylet was bent and kinked in multiple locations.One side of the outer polymide coating of the stylet was observed to be damaged near its break site and the damaged was observed to be extensive and semi-regularly patterned.The inner coating was observed to be bunched up on the core wire and plastically deformed at the distal end.The core wire was observed to be broken and the fracture surface appeared to be granular in texture, however one edge of the fracture surface was observed to be lustrous.Non-complaint tls stylet samples were pulled out of a catheter at an approximate 90° angle relative to the luer connector hub with and without pre-flushing and also with and without pressure on the stylet during removal.All three tests resulted in curling of the stylet like that seen in the returned sample.The stylet was also pull out of the t-lock quickly and at an approximate 90° angle, however the failure mode was not able to be recreated with this method.The shape, location, and nature of the damage observed on the stylet, the characteristics of the fracture site of the stylet, and the similarities observed during attempts to replicate the failure suggest the stylet was pulled against the catheter hub or another hard surface which caused the observed damage and ultimate fracture of the distal end of the stylet.As a note, the product ifu states: ¿never use force to remove the stylet¿ and ¿flush catheter through extension set prior to use.¿ a lot history review (lhr) of reaw0789 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to the sales rep that after the procedure, the wire came out kinked, sheared and appeared frayed.Nurse noted some of the copper coating had been stripped off exposing the inner layer blue wire.No patient injury was reported.

• Brand Name: GROSHONG PICC SHERLOCK TIP LOCATION SYSTEM 3F S/L BASIC TRAY
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6905315
• MDR Text Key: 88033140
• Report Number: 3006260740-2017-01752
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036064
• UDI-Public: (01)00801741036064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9755305
• Device Catalogue Number: 9755305
• Device Lot Number: REAW0789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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