MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redy0629 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that there was a packaging defect, missing a weld, so the device was not sterile.The device not used.

Event Description

It was reported that there was a packaging defect, missing a weld, so the device was not sterile.The device not used.

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, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unsealed packaging was confirmed and appears to be manufacturing related.One 4 fr sl powerpicc solo catheter kit was returned in its packaging.The product information on the label showed ref: 6194355 and lot: redy0629.The bottom side of the header bag was observed to be opened with no evidence of a seal present.An angled seal was present on the right bottom corner.Three photo samples of a 4 fr powerpicc solo catheter kit were also provided and corresponded with the returned physical sample.The first photo sample shows the catheter kit facing downwards.The kit components appeared to be present within the kit tray.The top and side indentions of the kit header bag seals were visible; however, evidence of a seal at the bottom of the packaging was not clearly visible.The second photo shows a closer view of the unsealed region.An angled seal compression area was observed at the corner of the header bag.A complete seal was not observed.The third photo shows the kit product label with lot: redy0629.The presence of an angled seal suggest the packaging was likely inserted at an angle during the manufacturing process leading to an unsealed area.The photos will be forwarded to the manufacturing facility for further evaluation.Reynosa evaluation complaint due to ¿unsealed packaging¿ was confirmed.According with the photo evaluation performed at reynosa facility and photo evaluation performed by vad field assurance the following was concluded: a portion of the powerpicc solo catheter kit was found to be unsealed.The header bag showed just an angled seal compression area what suggested the packaging was not correctly inserted/hold during the header bag sealing process leading an unsealed area.This condition was caused during the sealing process and it makes the device unsafe for our customer.Therefore, the cause of this condition is manufacturing related.A lot history review (lhr) of redy0629 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE)
• Type of Device: 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: 10118439
• MDR Text Key: 193954367
• Report Number: 3006260740-2020-01951
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741139079
• UDI-Public: (01)00801741139079
• Combination Product (y/n): N
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 6194355
• Device Lot Number: REDY0629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1