MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL25GA5/8IN; NEEDLE

Model Number	300253
Medical Device Problem Codes	Calcified (1077); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8281138, medical device expiration date: 2023-10-31, device manufacture date: 2018-12-14.Medical device lot #: 9072975, medical device expiration date: 2024-03-31, device manufacture date: 2019-05-14.Investigation summary: the customer issued a complaint for damaged box, missing certificate and label not clear detected during reception of goods.Photos of the damaged box and also the labels were made available by the customer.The review of the photos determined that inner bag was damaged and it was mentioned the box was damaged however the labels indicated as not readable were considered legible of the key information relating to the product.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Complaint conclusion: confirmed.
Event or Problem Description
It was reported that hypoint ndl25ga5/8in package was damaged and the label was unreadable.The following information was provided by the initial reporter: during checking the consignment we have observed that 9 box's received, 1 box received in damaged condition and material exposed to environment.We have not received coa with consignment.During material checking all container label not readable.

• Brand Name: HYPOINT NDL25GA5/8IN
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12284422
• Report Number: 8041187-2021-00691
• Device Sequence Number: 14413495
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2021

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: Lay User/Patient
• Device Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1