Catalog Number 301029 |
Device Problems
Break (1069); Volume Accuracy Problem (1675); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0071629, medical device expiration date: 02/28/2025, device manufacture date: 03/19/2020.Medical device lot #: 1005797, medical device expiration date: 12/31/2025, device manufacture date: 01/20/2021.Medical device lot #: 1005805, medical device expiration date: 12/31/2025, device manufacture date: 01/24/2021.Medical device lot #: the customer provided lot # 0240776.This does not match the catalog number provided.Medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: the customer provided lot #1036006.This does not match the catalog number provided.Medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: 0071629, medical device expiration date: 02/28/2025, device manufacture date: 03/19/2020.Medical device lot #: 0142212, medical device expiration date: 04/30/2025, device manufacture date: 05/28/2020.Medical device lot #: 0127987, medical device expiration date: 04/30/2025, device manufacture date: 03/13/2020.Medical device lot #: 0142212, medical device expiration date: 04/30/2025, device manufacture date: 05/28/2020.Medical device lot #: 1152292, medical device expiration date: 05/31/2026, device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that multiple defects were found from a collection of bd syringe luer-lok¿ tips.Defects include barrel/flange damage (9 occurrences), missing scale markings (2 occurrences), illegible/blurred scale markings (26 occurrences), scale markings permanency (13 occurrences), and plunger rod damage (5 occurrences).There was no patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "it is impossible to determine how many syringes come from the particular batch#.6 syringes with deformation, 2 unprinted, 10 syringes incomplete/no plunger - lot: 0071629/1005797/1005805; 12 syringes bad print, 6 syringes ink splatter, 1 syringe contamination top.- lot: 0240776/1036006; 1 syringe bad print, 7 syringes ink splashes, 3 bad plunger - lot: 0071629-0142212-0127987; 13 syringes bad print, 1 without rubber, 3 broken, 2 with plunger crooked, 3 contaminated/ink - lot: 0142212/1152292.".
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Manufacturer Narrative
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H6: investigation summary: fifty-one loose 10ml syringes were received (p/n 301029).Through visual inspection, multiple defects embedded foreign matter, missing plunger rod, distorted stopper, damaged barrel, damaged plunger rod, missing stopper and scale marking defects were observed.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Potential root cause for the missing plunger rod, distorted stopper, damaged barrel near flange, damaged plunger rod, and missing stopper defect are all associated with the assembly process.Potential root cause for the scale marking defects and barrel damage on samples with scale marking issues is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batches 0071629, 0127987, 0142212, 1005797, 1005805, and 1152292 are considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.
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Event Description
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It was reported that multiple defects were found from a collection of bd syringe luer-lok¿ tips.Defects include barrel/flange damage (9 occurrences), missing scale markings (2 occurrences), illegible/blurred scale markings (26 occurrences), scale markings permanency (13 occurrences), and plunger rod damage (5 occurrences).There was no patient impact.The following information was provided by the initial reporter, translated from dutch to english: "it is impossible to determine how many syringes come from the particular batch #.6 syringes with deformation, 2 unprinted, 10 syringes incomplete/no plunger - lot: 0071629/1005797/1005805.12 syringes bad print, 6 syringes ink splatter, 1 syringe contamination top.- lot: 0240776/1036006.1 syringe bad print, 7 syringes ink splashes, 3 bad plunger - lot: 0071629-0142212-0127987.13 syringes bad print, 1 without rubber, 3 broken, 2 with plunger crooked, 3 contaminated/ink - lot: 0142212/1152292.".
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Search Alerts/Recalls
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