MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PG PRO 20G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120100
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeu0181 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that patient accessing vessel with a powerglide.Wire ran smoothly, per nurse placing device.Catheter deployed and resistance met.There may have been some manipulation of the wire and catheter back and forth after resistance felt.Wire and device removed while catheter remained in the patient's arm.Catheter got stuck in the patient's skin when last centimeter of catheter was trying to be removed.Last centimeter of catheter broke off under patient¿s skin.That part of the catheter was removed from the patient¿s arm safely.
Event or Problem Description
It was reported that patient accessing vessel with a powerglide.Wire ran smoothly, per nurse placing device.Catheter deployed and resistance met.There may have been some manipulation of the wire and catheter back and forth after resistance felt.Wire and device removed while catheter remained in the patient's arm.Cather got stuck in the patient's skin when last centimeter of catheter was trying to be removed.Last centimeter of catheter broke off under patient¿s skin.That part of the catheter was removed from the patient¿s arm safely.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide catheter was confirmed.The product returned for evaluation was two 20ga x 10cm powerglide pro midline catheters.Blood residue was observed throughout the first sample (sample 1).The catheter terminated approximately 1cm from the distal tip.The tip appeared irregular.The distal fragment was not returned for evaluation.The second catheter (sample 2) was intact and appeared free of blood residues.Microscopic inspection of the distal end of sample 1 confirmed an irregular break.The break surface was glossy and sharply defined.The break exhibited a tapered profile and a longitudinal scoring mark was observed on the inside surface of the catheter leading into the break.The second sample appeared unremarkable.The break features exhibited by sample 1 were consistent with damage caused by retraction against the needle tip.Such damage can occur if the catheter is withdrawn onto the needle following advancement and if the needle is re-inserted into the catheter following advancement.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿.

• Brand Name: PG PRO 20G 10CM BASIC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11069329
• Report Number: 3006260740-2020-21103
• Device Sequence Number: 16827243
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F120100
• Device Catalogue Number: F120100
• Device Lot Number: REEU0181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/25/2021
• 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: Required Intervention