MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX PORT ACCESS KIT 20G X 0.75 IN; HYPODERMIC SINGLE LUMEN NEEDLE.

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/10/2020
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) of redx1520 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a port kit was opened at bedside to access patient's port and a brown flake was found within in the packaging.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material is inconclusive due to the state of the returned sample.One 20 g x 0.75 in.Powerloc max port access kit was returned for evaluation.An initial visual observation showed the kit was returned open.A brown residue was observed to be taped on to the interior of the csr wrap of the kit.A circle was drawn on the csr wrap around this residue.The tape was removed from the csr wrap and a microscopic observation revealed the brown residue stuck in the adhesive of the tape was mostly flat and fibrous.Because the kit was returned open, it was difficult to assess when or where the residue came into contact with the kit.Possible causes include contamination of the kit before or after it was sealed.A lot history review (lhr) of redx1520 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a port kit was opened at bedside to access patient's port and a brown flake was found within in the packaging.

• Brand Name: POWERLOC MAX PORT ACCESS KIT 20G X 0.75 IN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE.
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9856396
• Report Number: 3006260740-2020-00892
• Device Sequence Number: 2610928
• Product Code: FPA
• UDI-Device Identifier: 00801741044298
• UDI-Public: (01)00801741044298
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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 Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 2142075
• Device Lot Number: REDX1520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1