MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional 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 leak was inconclusive because no sample was returned to vad for evaluation.Based on the description of the reported event, possible contributing factors include sharp instrument damage and stylet damage; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.A lot history review (lhr) of rebz0505 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the after insertion a hole was noticed in the catheter.The attempt happened in the upper limb guided by doppler ultrasound.
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 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 hole is confirmed and was determined to be use related.One 4 fr single lumen per-q-cath, one stiffening stylet, one excalibur introducer sheath, and a product information sticker were returned for evaluation.An initial visual observation showed use residue on the returned samples.The stiffening stylet was observed to be bent and kinked in several locations, and the stylet was observed to be completely out of the t-lock.The catheter was flushed with a 12 ml syringe of water and a spraying leak was observed just distal to the strain relief.A microscopic observation revealed a large longitudinal split in the catheter at the distal end of the strain relief.The edges of the split were observed to be rough and curved slightly inward.The catheter was dissected and more extensive damage was observed on the inner wall of the catheter around the observed split; especially at the proximal corner of the split.The type of damage observed on and within the returned catheter was most-likely caused by manipulation of the stiffening stylet within the catheter without first flushing the catheter and/or rapid or forceful withdrawal of the stylet from the catheter.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¿ and ¿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.Once the stylet is out, advance the catheter into the desired position.¿ a lot history review (lhr) of rebz0505 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the after insertion a hole was noticed in the catheter.The attempt happened in the upper limb guided by doppler ultrasound.

• Brand Name: PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8076066
• Report Number: 3006260740-2018-03229
• Device Sequence Number: 1516567
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4134105
• Device Lot Number: REBZ0505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR