MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET 20G X 0.75IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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 refu0856 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refu0856) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported, "the needles came damaged, some of them were dusty and the two of them came in damaged box, so they are not sterile anymore." this report addresses the first of the two needles that were damaged.
Event or Problem Description
It was reported, "the needles came damaged, some of them were dusty and the two of them came in damaged box, so they are not sterile anymore." this report addresses the first of the two needles that were damaged.
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 packaging is confirmed; however, the exact cause is unknown.Two photographs of two winged infusion set kits were returned for evaluation.An initial visual observation of the photographs showed small tears in the tyvek of both kits.The majority of the packaging of the kits was observed to be wrinkled.A grey-colored residue was observed on the front of the kits.The clear plastic of the packaging was also observed to be damaged, and the shape of this damage on at least one of the kits in the returned photographs was found to be very similar the shape of the pinch clamp of the product within the kit.It could not be determined from the returned photographs when or where the samples were damaged.Possible contributing factors include damage during shipping, storage, or handling.H3 other text : evaluation findings are in section h.11.

• Brand Name: WINGED INFUSION SET 20G X 0.75IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12870251
• Report Number: 3006260740-2021-05022
• Device Sequence Number: 12268396
• Product Code: FMI
• UDI-Device Identifier: 00801741065804
• UDI-Public: (01)00801741065804
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 0604190
• Device Lot Number: REFU0856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown