MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (SINGLE-LUMEN)(65CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 4135105

Device Problems Split (2537); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2017

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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 damaged catheter is confirmed and was determined to be use related.One 4 fr per-q-cath was returned for evaluation in two segments.An initial visual observation showed use residue on the stylet and a yellowish residue was observed within the catheter between 47 cm and 48 cm depth markers.The distal end of the stylet was observed to be positioned between the 45 cm and 46 cm depth markers.Both catheter segments were flushed with a 12 ml syringe of water and both segments were found to be patent to infusion and aspiration; however, a leak was observed near the distal end of the strain relief of the hub.A microscopic observation revealed a large, longitudinal split in the catheter at the end of the strain relief.A repeating pattern of diagonal lines was observed in the catheter material near the split.The catheter was dissected in order to examine the inner wall of the catheter and additional, superficial damage was observed to extend proximal to the split on the interior of the catheter the location, shape, and extent of the damage observed on and within the catheter are indicative of stylet damage.The product ifu states: ¿flush the catheter with sterile normal saline or heparinized saline prior to use.Catheter stylet must be wetted prior to stylet repositioning or withdrawal.¿ also, ¿never use force to remove the stylet.Resistance can damage the catheter.¿ 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 that while flushing prior to insertion the catheter was noted to be damaged and was unable to be successfully flushed.The catheter was not used on the patient.No other information was provided.3/29/2018 - the returned catheter has a large split near the distal hub.The returned catheter also has blood residue on the stylet indicating use on a patient.

• Brand Name: PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (SINGLE-LUMEN)(65CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 7448343
• MDR Text Key: 106188770
• Report Number: 3006260740-2018-00771
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074905
• UDI-Public: (01)00801741074905
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4135105
• Device Catalogue Number: 4135105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/28/2018
• 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