MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION KIT; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	9295108D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reas1421 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility, via the sales rep, that one of the procedure nurses went to use a product on (b)(6) 2017 and the packaging seal was broken, so she could not use the product.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the seal was open was confirmed.It appears that the kit was opened outside bard control; however, when or how the seal was opened could not be determined.One powerpicc solo kit, which resembles the item in the provided photograph, was returned for investigation.Part number 9295108d and lot number reas1421 were on the label.The expiration date was 2017-10-28.The tyvek flap was separated from the top edge of the pouch and was noted to be wrinkled and crumpled away from the top edge of the pouch.Evidence of a complete seal was observed where the tyvek had been peeled away from the pouch.A white colored band was observed along the edge of the pouch where material was transferred from the tyvek flap.No gaps were noted in the material transfer along the edge of the pouch.The width of the seal was consistent and uniform.No other damage was observed on the tyvek, the pouch, or the wrapped kit contained therein.A tactual investigation revealed that the remainder of the seal was intact and adhered to the bag.The packaging exhibits evidence that it was properly sealed, but must have been inadvertently opened and may have occurred outside bard control due to improper handling or storage conditions.A review of the manufacturing records (dhr, mrr¿s, scrap and mfg.Process changes) showed no evidence that the reported event was caused by the manufacturing process.
Event or Problem Description
It was reported by the facility, via the sales rep, that one of the procedure nurses went to use a product on (b)(6) 2017 and the packaging seal was broken, so she could not use the product.

• Brand Name: 5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION KIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6692367
• Report Number: 3006260740-2017-00989
• Device Sequence Number: 16390035
• Product Code: LJS
• UDI-Device Identifier: 00801741035760
• UDI-Public: (01)00801741035760
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K0702230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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 Expiration Date: 12/31/2019
• Device Model Number: 9295108D
• Device Catalogue Number: 9295108D
• Device Lot Number: REAS1421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1