MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional 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) of reat2155 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that micro holes were noted in the catheter after infusion of sodium chloride 0.9% before insertion in the patient.Device was not used on the patient.
Additional 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 leaking catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 3fr s/l groshong catheter.Usage residues were observed throughout the sample.The catheter was received with an inlaid stylet.The catheter had been manipulated on the stylet connector cannula.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, multiple leaks were observed between the 31cm and 36cm depth markings.Tactile inspection of the sample revealed tensile weakness in the vicinity of the leaks.Microscopic inspection of the leak sites revealed multiple diagonally and longitudinally aligned splits.Diagonally aligned impressions were observed in the vicinity of the leaks.Following longitudinal bisection of the sample in the vicinity of the splits, inspection of the inside surface revealed abundant mechanical damage.The manipulation of the catheter on the stylet connector cannula and the internal surface features were consistent with catheter damage caused by the inlaid stylet.Such damage typically occurs if the stylet is manipulated or removal is attempted prior to wetting and /or if removal is attempted through a tortuous path.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.
Event or Problem Description
It was reported that micro holes were noted in the catheter after infusion of sodium chloride 0.9% before insertion in the patient.Device was not used on the patient.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH MICROINTRODUCER
• Common Device Name: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6642375
• Report Number: 3006260740-2017-00783
• Device Sequence Number: 16320344
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757(17)190628(10)REAT2155
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K926331
• 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): 08/09/2017

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 Expiration Date: 06/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 7755305
• Device Lot Number: REAT2155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Weight: 8