MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (SINGLE-LUMEN)(65CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx2384 showed three similar product complaint(s) from this lot number.The complaints for this lot number (recx2384 ) have been reported from the same facility.
Event or Problem Description
It was reported on (b)(6) 2021 the procedure was begun, at the moment of removing the guidewire it presented resistance, and after performing some unsuccessful handling in an attempt to remove it, it was required to remove the catheter.It was noticed that the catheter was ruptured in its extension.It seems that the rupture was caused by the guidewire that got stuck inside the catheter.There was no exposure to medications of bodily fluids to health professional's mucous or skin.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a catheter leak is confirmed but the exact cause could not be determined from the video provided.One video sample of a 5 fr perqcath catheter was provided for evaluation.The catheter is shown outside of patient use; however, blood residue appears to be present on the surface.A syringe is attached to the hub and a clear fluid is being infused.Fluid is observed to leak at the region between the hub and molded wing.The damage present on the device could not be clearly inspected from the video and due to the lack of a returned physical sample.The event description indicates that resistance was experienced during stylet removal which may be a likely contributing factor to the cause of the catheter leak.Since fluid was observed to leak, the complaint is confirmed but the exact cause could not be determined.The instructions for use (ifu) caution, ¿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.¿.
Event or Problem Description
It was reported on april 12, 2021 the procedure had begun, at the moment of removing the guidewire it presented resistance, and after performing some unsuccessful handling in an attempt to remove it, it was required to remove the catheter.It was noticed that the catheter was ruptured in its extension.It seems that the rupture was caused by the guidewire that got stuck inside the catheter.It was stated there was no exposure to medications of bodily fluids to health professional's mucous or skin.

• Brand Name: PER-Q-CATH PLUS PICC WITH STIFFENING STYLET WIRE 5F (SINGLE-LUMEN)(65CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• MDR Report Key: 11791344
• Report Number: 3006260740-2021-01757
• Device Sequence Number: 3098652
• Product Code: LJS
• UDI-Device Identifier: 00801741074905
• UDI-Public: (01)00801741074905
• 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: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 4135105
• Device Lot Number: RECX2384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR