MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO, REINFORCED TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported a powerglide where the safety mechanism that is supposed to cover the needle tip when inserted broke off/didn't engage with insertion.Was there any patient harm reported? no harm, but the patient had to be stuck a second time.What they're being treated for: stroke.No other information provided.
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 that the safety mechanism separated from the needle was confirmed, but the exact mechanism of damage was undetermined.One powerglide pro deployment system was returned for investigation without the catheter.The guidewire was fully extended through the needle.The safety mechanism was received separate from the needle.A microscopic examination of the safety mechanism revealed nothing remarkable.The o-ring was intact and no damage was observed on the components.A microscopic examination of the needle revealed nothing remarkable.The dimensions of the needle were within specification.Since the reported event was demonstrated on the returned sample, the complaint was confirmed; however, no distinguishing features pointed to a specific root cause.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported a powerglide where the safety mechanism that is supposed to cover the needle tip when inserted broke off/didn¿t engage with insertion.¿ was there any patient harm reported? no harm, but the patient had to be stuck a second time.¿ what they¿re being treated for: stroke.No other information provided.

• Brand Name: POWERGLIDE PRO, REINFORCED TIP
• 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: 11864544
• Report Number: 3006260740-2021-01932
• Device Sequence Number: 3589236
• Product Code: FOZ
• UDI-Device Identifier: 00801741140624
• UDI-Public: (01)00801741140624
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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 Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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 Weight: 61