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

Model Number	300263
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2020
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 #: 9155552, medical device expiration date: 2024-06-30, device manufacture date: 2019-07-22.Medical device lot #: 9287090, medical device expiration date: 2024-10-31, device manufacture date: 2019-11-20.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).".
Event or Problem Description
It was reported that an unspecified number of hypoint ndl22ga1-1/2in tw leaked at the connection site during use.The following was reported by the initial reporter: "we inform you that we received a new complaint for a needle quality issue (¿when he was injecting the liquid inside the bottle, leaked medication by the connection instead the tip of the needle¿).Needles 22g (hypoint ndl 22ga1-1/2in tw) impacted: (b)(4) (supplier lot 9155552) et (b)(4) (supplier lot 9287090.The sample for this complaint is not available.".
Additional Manufacturer Narrative
H6:investigation summary: the customer issued a complaint for connectivity issue, leakage detected during use.No samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.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), and were manufactured and released according to applicable procedures and specifications.Based on the investigation conclusion, bd was not able to confirm the detection of the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.
Event or Problem Description
It was reported that an unspecified number of hypoint ndl22ga1-1/2in tw leaked at the connection site during use.The following was reported by the initial reporter: "we inform you that we received a new complaint for a needle quality issue (¿when he was injecting the liquid inside the bottle, leaked medication by the connection instead the tip of the needle¿).Needles 22g (hypoint ndl 22ga1-1/2in tw) impacted: 19090090 (supplier lot 9155552) et 20020027, (supplier lot 9287090.The sample for this complaint is not available.".

• Brand Name: HYPOINT NDL22GA1-1/2IN TW
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11234275
• Report Number: 8041187-2021-00055
• Device Sequence Number: 3374389
• Product Code: FPA
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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 Expiration Date: 10/31/2024
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 9287090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1