MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 20G X .75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
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 redn2186 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle was opened and dirty.Packaging was not damaged.Device was not used on the patient.
Event or Problem Description
It was reported that the needle was opened and dirty.Packaging was not damaged.Device was not used on the patient.
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 damaged and discolored packaging is confirmed but the exact cause could not be determined from the photo provided.One photo of a safety huber infusion set packaging was provided for evaluation.The product number visible shows ref: 573112; however, the lot cannot be clearly seen.The initial four characters show ¿redn¿ which corresponds with the reported lot number "redn2186".The packaging label surface is damaged and has a dark, stained discoloration.A tear in the packaging is present on the right portion of the label and is surrounded by the discoloration and wrinkling of the label.The location and source of the damage remains unknown and no evidence to suggest the event occurred within bd's control was observed.A review of the dhr/manufacturing records showed that no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.This is the only complaint associated to the reported lot number.A lot history review (lhr) of redn2186 showed no other similar product complaint(s) from this lot number.

• Brand Name: SAFETY HUBER 20G X .75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10372640
• Report Number: 3006260740-2020-02798
• Device Sequence Number: 16924235
• Product Code: FPA
• UDI-Device Identifier: 00801741044724
• UDI-Public: (01)00801741044724
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 573112
• Device Lot Number: REDN2186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1