MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305782
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one photo and one sample with open packaging was received by our quality team for evaluation.From the photo, damage was observed on the hub collar.The sample was subjected to visual inspection and the eclipse hub collar was observed to be dented.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The assembly process was reviewed, and the discharge station was found to contact the eclipse hub collar.The probable root cause could be that there were stray parts at the discharge station which was not effectively cleared off during housekeeping.The stray parts resulted in the subsequent incoming parts reaching the discharge station to be jammed and continuously hit by each other eventually causing damage to the hub collar and then falling into the good part bin.This could be an isolated case due to improper housekeeping.The eclipse assembly production technician will be retrained on the housekeeping checklist with an emphasize to clear off all stray parts at the discharge station to prevent possible jams of parts.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced a broken barrel.The following information was provided by the initial reporter: broken barrel.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced a broken barrel.The following information was provided by the initial reporter: broken barrel.
Additional Manufacturer Narrative
H6: investigation summary one photo and one sample in open packaging were received by our quality team for evaluation.From the photo and the sample, a crack line was observed on the barrel.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The eclipse primary packaging was reviewed.There is no machine contact on a large barrel surface which could press on the barrel to create the crack line.There is a small contact with the barrel surface during pick and place of the barrel, however, the pick and place gripper is made of rubber and via the suction motion which is unlikely to generate the crack line.The syringe assembly line was reviewed.Probable root cause could be due to the leak test lowering tooling screw loosening, causing the barrel to be unable to sit properly when the part is transferring to the exercise dial pocket.This eventually led to a jammed part and a cracked barrel.H3 other text : see h10.
Additional Manufacturer Narrative
H6: investigation summary: one photo and one sample in open packaging were received by our quality team for evaluation.From the photo and the sample, a crack line was observed on the barrel.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The eclipse primary packaging was reviewed.There is no machine contact on a large barrel surface which could press on the barrel to create the crack line.There is a small contact with the barrel surface during pick and place of the barrel, however, the pick and place gripper is made of rubber and via the suction motion which is unlikely to generate the crack line.The syringe assembly line was reviewed.Probable root cause could be due to the leak test lowering tooling screw loosening, causing the barrel to be unable to sit properly when the part is transferring to the exercise dial pocket.This eventually led to a jammed part and a cracked barrel.Checking the condition of the leak test lower tooling screw, changing, and replacing if required will be added to the yearly assembly preventative maintenance checklist.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that the bd eclipse¿ needle experienced a broken barrel.The following information was provided by the initial reporter: broken barrel.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15316896
• Report Number: 8041187-2022-00505
• Device Sequence Number: 5505021
• Product Code: FMI
• UDI-Device Identifier: 30382903057826
• UDI-Public: 30382903057826
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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 Model Number: 305782
• Device Catalogue Number: 305782
• Device Lot Number: 1330252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 09/12/2022; 09/27/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/26/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2021
• 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
• Patient Sex: Unknown