MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redu4469 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redu4469) have been reported from the same facility.
Event or Problem Description
It was reported "we have had an issue with one of our powerglide pro devices today.It was inserted per normal technique and when the was withdrawn it was noted that about 2 cm of the plastic sheath was missing.The md ordered an xray of the pt and we noted that the sheath was still in the pt¿s arm.Pt is fine.No problems at all but this is very weird occurrence.The nurse performing the procedure has been placing advanced lines since 2015.We pulled 4-5 more devices and attempted to recreate this incident and it was absolutely impossible as the sheath is super flexible and stretches when pulled and we were unable to break it." 3/12/2020 - additional information received: the complainant reported that surgeons were consulted and it was determined to leave the retained catheter segment in place.
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 fractured catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter.Usage residues were observed throughout the sample.The catheter terminated 5.7cm from the molded joint.The distal catheter fragment was not returned for evaluation.Microscopic inspection of the distal end of the catheter revealed a partially granular fracture surface.A glossy region was observed.The glossy region corresponded to a v-shaped section of the fracture profile.A longitudinal scoring mark was observed on the inside surface of the catheter leading into the point of the v-shape.The fracture features and scoring mark leading into the fracture were consistent with catheter damage caused by contact with the needle tip.Such damage can occur if the catheter is pulled back onto the needle during attempted placement and if the needle is inserted further following advancement of the catheter.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.¿ a lot history review (lhr) of redu4469 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redu4469) have been reported from the same facility.
Event or Problem Description
It was reported "we have had an issue with one of our powerglide pro devices today.It was inserted per normal technique and when the was withdrawn it was noted that about 2 cm of the plastic sheath was missing.The md ordered an xray of the pt and we noted that the sheath was still in the pt¿s arm.Pt is fine.No problems at all but this is very weird occurrence.The nurse performing the procedure has been placing advanced lines since 2015.We pulled 4-5 more devices and attempted to recreate this incident and it was absolutely impossible as the sheath is super flexible and stretches when pulled and we were unable to break it." (b)(6)2020 - additional information received: the complainant reported that surgeons were consulted and it was determined to leave the retained catheter segment in place.

• Brand Name: PG PRO 20G 8CM BASIC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9913804
• Report Number: 3006260740-2020-01102
• Device Sequence Number: 3296473
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• 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): 04/16/2020

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 Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: F120080
• Device Lot Number: REDU4469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 61