MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 redr3319 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion, there was some bleeding while the introducer was in place due to a hole(in a spot where there should not be) in the top part of the introducer.Patient is unharmed.The rn that placed the device stated, "i evaluated it after the procedure by flushing saline through it, to see where the integrity issue was.It appears that there is a crack, not actual hole, where i put arrow for you to look.There was not any harm to the patient, i just placed gauze until i could trim my picc and remove the inter-core of the introducer that was leaking.The part was not indwelling into the patient, and the rest of the integrity of the introducer was fine.".
Event or Problem Description
It was reported that during insertion, there was some bleeding while the introducer was in place due to a hole (in a spot where there should not be) in the top part of the introducer.Patient is unharmed.The rn that placed the device stated, "i evaluated it after the procedure by flushing saline through it, to see where the integrity issue was.It appears that there is a crack, not actual hole, where i put arrow for you to look.There was not any harm to the patient, i just placed gauze until i could trim my picc and remove the inter-core of the introducer that was leaking.The part was not indwelling into the patient, and the rest of the integrity of the introducer was fine.".
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 damaged dilator hub was confirmed and the cause appeared to be manufacturing related.One vessel dilator from a microintroducer was returned for investigation.The dilator was received without the introducer sheath.A functional test revealed fluid leaking from the side of the luer adaptor hub.The leak site in the hub was microscopically examined.A 0.070" longitudinal breach was found within one of the two circular features of the hub.The breach appeared to be the result of a molding flaw.The hub was bisected and appearance of the breach appeared similar within the luer taper.The manufacturing facility was notified of this complaint.Reynosa evaluation: complaint due to ¿a breach on dilator hub¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual and microscopic visual and functional testing performed at vad lab it was concluded that a breach was found to be present on the white dilator hub.This condition (short shot on the piece) was caused during the hub molding process.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of redr3319 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion, there was some bleeding while the introducer was in place due to a hole(in a spot where there should not be) in the top part of the introducer.Patient is unharmed.The rn that placed the device stated, "i evaluated it after the procedure by flushing saline through it, to see where the integrity issue was.It appears that there is a crack, not actual hole, where i put arrow for you to look.There was not any harm to the patient, i just placed gauze until i could trim my picc and remove the inter-core of the introducer that was leaking.The part was not indwelling into the patient, and the rest of the integrity of the introducer was fine." (b)(6) 2020- medwatch received stated, "during process of insertion, access to vein initiated as per procedure, guide wire advanced needle removed.Micro-introducer inserted over wire, cap applied, tourniquet removed.(this is usually where access is secured, and then picc s trimmed, and inter piece of micro-introducer is removed.) there was excess bleeding noted.Upon assessment of where this was coming from, which was no insertion site a the patients skin area, noticed it was coming from top side of the core of the micro-introducer.This piece is removed when advancing the catheter.A 4x4 gauze was wrapped around top of introducer and picc trimmed, and then this piece was removed and catheter advanced without difficulty.This piece was never inside the patient.After procedure evaluated piece using flushing of saline through piece, appeared to be a crack in top side area, the rest of the introducer was intact.There was not any harm to the patient, the piece was saved as well as lot number and had been reported to vendor.".
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 damaged dilator hub was confirmed and the cause appeared to be manufacturing related.One vessel dilator from a microintroducer was returned for investigation.The dilator was received without the introducer sheath.A functional test revealed fluid leaking from the side of the luer adaptor hub.The leak site in the hub was microscopically examined.A 0.070" longitudinal breach was found within one of the two circular features of the hub.The breach appeared to be the result of a molding flaw.The hub was bisected and appearance of the breach appeared similar within the luer taper.The manufacturing facility was notified of this complaint.Reynosa evaluation: complaint due to ¿a breach on dilator hub¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual and microscopic visual and functional testing performed at vad lab it was concluded that a breach was found to be present on the white dilator hub.This condition (short shot on the piece) was caused during the hub molding process.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of redr3319 showed no other similar product complaint(s) from this lot number.- attachment: [1402000000-2019-8007 file 1516566.Pdf].

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 9411156
• Report Number: 3006260740-2019-03740
• Device Sequence Number: 17172426
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

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: 1295108FD
• Device Lot Number: REDR3319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/31/2020; 02/19/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/12/2020; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR