MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL22GA1-1/2IN TW; NEEDLE

Model Number	300263
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for clogged needle detected during customer usage.As no sample was provided to bdm-ps for analysis and no additional information is available, the 8d team leader is not able to delve deeper into the investigation and correlate this symptom with a potential cause linked to bdm-ps syringe manufacturing process.However, based on the description bd assigned a quality criteria that is identified in the agreed specification.After reviewing the occurrence is within the specification and no further action will be assigned and report will not be updated on receipt of additional sample information.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 met all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw needle was clogged.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality problem (¿when he went to prepare the medication for use, he reported that the syringe did not pull or inject the liquid to make the mixture¿).

• Brand Name: HYPOINT NDL22GA1-1/2IN TW
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12284493
• Report Number: 8041187-2021-00692
• Device Sequence Number: 19793830
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070440
• 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): 08/02/2021

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: Other
• Device Expiration Date: 03/31/2025
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 0071191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• 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